Drug Information

View drug alerts Information in California, Georgia, or New York
 
The Drug Information Center has a wealth of information to help you understand how drugs impact your health as well as their place in today's healthcare environment. 
 
The information you'll find in the center covers a number of important topics ranging from drug safety and side effects to medication costs and errors. You'll also notice from time to time we will display drug alerts. These alerts will let you know when a New Drug is put on the market, if a drug has been recalled, and if a drug has a new indication or use. 
 
 
Drug Name Drug Reason Date
Promacta
The Food and Drug Administration (FDA) approved Promacta® (eltrombopag tablets) as first-line treatment for adults and children 2 years and older with severe aplastic anemia (SAA) in combination with standard immunosuppressive therapy (IST). Source: FDA website
New Indication 11-16-18
Venclexta
The Food and Drug Administration (FDA) approved Venclexta® (venetoclax tablets) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in individuals aged 75 years or older, or for those ineligible for intensive induction chemotherapy due to comorbidities. It is intended for use in combination with a hypomethylating agent (azacitidine or decitabine) or low-dose cytarabine (LDAC). Source: FDA website
New Indication 11-21-18
Aemcolo
The Food and Drug Administration (FDA) approved AemcoloTM (rifamycin delayed-release tablets) for the treatment of adults with travelers' diarrhea caused by non-invasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool. Source: FDA website
New Formulation 11-16-18
Actemra ACTPen
The Food and Drug Administration (FDA) approved Actemra® ACTPen (tocilizumab prefilled autoinjector) for adults with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to 1 or more disease-modifying anti-rheumatic drugs (DMARDs), and for adults with giant cell arteritis (GCA). In addition, for individuals aged 2 and older with polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA), ACTPen can be administered by caregivers; the autoinjector has not been tested for self-injection in pediatrics. Source: FDA website
New Formulation 11-26-18
Temixys
The Food and Drug Administration (FDA) approved Temixys (lamivudine/tenofovir disoproxil fumarate tablets) for use in combination with other antiretrovirals for the treatment of human immunodeficiency virus (HIV)-1 infection in adults and pediatric individuals weighing at least 35 kg. Source: FDA website
New Formulation 11-16-18
Gamifant
The Food and Drug Administration (FDA) approved Gamifant® (emapalumab injection) for the treatment of pediatric (newborn and older) and adult individuals with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Source: FDA website
New Drug 11-20-18
Daurismo
The Food and Drug Administration (FDA) approved DaurismoTM (glasdegib tablets) for the first-line treatment of acute myeloid leukemia (AML) in adults 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy. Source: FDA website
New Drug 11-21-18
Vitrakvi
The Food and Drug Administration (FDA) approved Vitrakvi® (larotrectinib capsules and oral solution) for the treatment of individuals with solid tumors that have neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. Source: FDA website
New Drug 11-26-18
Xospata
The Food and Drug Administration (FDA) approved Xospata® (gilteritinib tablets) for the treatment of adults who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. Source: FDA website
New Drug 11-28-18
Firdapse
The Food and Drug Administration (FDA) approved Firdapse® (amifampridine tablets) for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. Source: FDA website
New Drug 11-28-18
Sodium chloride
Fresenius Kabi announced a voluntary recall of sodium chloride injection by Fresenius Kabi due to product labeling incorrectly stating stoppers do not contain latex. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm626450.htm Source: FDA website
Drug Recall 11-23-18
Valsartan-containing products by Mylan
Mylan announces a voluntary recall of 15 lots of valsartan tablets, amlodipine/valsartan tablets, and valsartan/hydrochlorothiazide tablets due to the detection of trace amounts of an impurity found in active pharmaceutical ingredient. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm626367.htm Source: FDA website
Drug Recall 11-21-18
Valsartan-containing products by Teva
Teva announced a voluntary recall of all amlodipine/valsartan tablets and amlodipine/valsartan/hydrochlorothiazide tablets that are within expiry due to the detection of trace amounts of an impurity found in active pharmaceutical ingredient. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm626802.htm Source: FDA website
Drug Recall 11-27-18
ThermaCare HeatWraps by Pfizer
Pfizer Consumer Healthcare announced a voluntary recall of six lots of ThermaCare® HeatWrap due to the potential to leak ingredients that are contained in the heat cell wrap. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm626671.htm Source: FDA website
Drug Recall 11-26-18
Pharm D Solutions
The Food and Drug Administration (FDA) is alerting healthcare providers and consumers not to use drug products intended to be sterile that are produced and distributed by Pharm D Solutions due to lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Drugs/DrugSafety/ucm626213.htm Source: FDA website
Drug Warning 11-19-18
Gilenya
The Food and Drug Administration (FDA) is warning that when the multiple sclerosis (MS) drug Gilenya® (fingolimod capsules) is stopped, the disease can become much worse than before the medication was started or while it was being taken. This MS worsening is rare but can result in permanent disability. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm626264.htm Source: FDA website
Drug Warning 11-20-18
Idhifa
The Food and Drug Administration (FDA) is warning that signs and symptoms of a life-threatening side effect called differentiation syndrome are not being recognized in individuals receiving the acute myeloid leukemia medicine Idhifa® (enasidenib tablets). The prescribing information and Medication Guide already contain a warning about differentiation syndrome. The agency is alerting health care providers and consumers about the need for early recognition and aggressive management of differentiation syndrome to lessen the likelihood of serious illness and death. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Drugs/DrugSafety/ucm626923.htm Source: FDA website
Drug Warning 11-29-18
Lemtrada
The Food and Drug Administration (FDA) is warning that rare but serious cases of stroke and tears in the lining of arteries in the head and neck have occurred in individuals with multiple sclerosis (MS) shortly after they received Lemtrada® (alemtuzumab injection). These problems can lead to permanent disability and death. A new warning has been added to the product labeling. Alemtuzumab is also approved under the brand name Campath® to treat B-cell chronic lymphocytic leukemia (B-CLL). The Campath drug label will also be updated. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Drugs/DrugSafety/ucm624247.htm Source: FDA website
Drug Warning 11-29-18
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of individuals with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Source: FDA website
New Indication 11-12-18
Oralair
The Food and Drug Administration (FDA) approved Oralair® (grass allergen extract sublingual tablet) for the treatment of grass pollen-induced allergic rhinitis in pediatric individuals aged 5-9 years. Source: FDA website
New Indication 11-14-18
Adcetris
The Food and Drug Administration (FDA) approved Adcetris® (brentuximab vedotin injection) in combination with chemotherapy for adults with certain types of peripheral T-cell lymphoma (PTCL). Source: FDA website
New Indication 11-18-18
Yupelri
The Food and Drug Administration (FDA) approved YupelriTM (revefenacin oral inhalation) for the maintenance treatment of individuals with chronic obstructive pulmonary disease (COPD. Source: FDA website
New Drug 11-09-18
Implanted Pumps
The Food and Drug Administration (FDA) is aware that individuals undergoing treatment or management of pain are commonly given pain medicines via intrathecal administration that are not FDA approved for use with the implanted pump. The agency is recommending caution when selecting pain medicine for intrathecal administration. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm625862.htm Source: FDA website
Drug Warning 11-14-18
Hemlibra
The Food and Drug Administration (FDA) approved Hemlibra® (emicizumab injection) for prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric individuals with hemophilia A with or without factor VIII inhibitors. Source: FDA website
New Indication 10-04-18
Gardasil 9
The Food and Drug Administration (FDA) approved Gardasil® 9 (human papillomavirus 9-valent vaccine injection) for vaccination in women and men aged 27 through 45 years. Source: FDA website
New Indication 10-05-18
Seysara
The Food and Drug Administration (FDA) approved SeysaraTM (sarecycline tablets) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in individuals 9 years and older. Source: FDA website
New Drug 10-02-18
Nuzyra
The Food and Drug Administration (FDA) approved NuzyraTM (omadacycline tablets and injection) for the treatment of adults with community-acquired bacterial pneumonia and acute skin and skin structure infections. Source: FDA website
New Drug 10-02-18
Tegsedi
The Food and Drug Administration (FDA) approved TegsediTM (inotersen injection) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Source: FDA website
New Drug 10-05-18
Revcovi
The Food and Drug Administration (FDA) approved RevcoviTM (elapegademase injection) for the treatment of adenosine deaminase severe combined immune deficiency. Source: FDA website
New Drug 10-05-18
Silver Star Brands
Silver Star Brands announced a voluntary recall of six products for humans and two for pets due to microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm622488.htm Source: FDA website
Drug Recall 10-03-18
Granix
The Food and Drug Administration (FDA) approved Granix® (tbo-filgrastim injection) to include reduction of duration of severe neutropenia in pediatric individuals 1 month and older with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with clinically significant incidence of febrile neutropenia. Source: FDA website
New Indication 08-07-18
Orkambi
The Food and Drug Administration (FDA) approved Orkambi® (lumacaftor/ivacaftor tablets and oral granules) to include use in children with cystic fibrosis (CF) ages two years through five years who have two copies of the F508del-CFTR mutation. Source: FDA website
New Indication 08-07-18
Signifor LAR
The Food and Drug Administration (FDA) approved Signifor® LAR (pasireotide pamoate injection) for the treatment of individuals with Cushing’s disease for whom pituitary surgery is not an option or has not been curative. Source: FDA website
New Indication 06-29-18
Jornay PM
The Food and Drug Administration (FDA) approved Jornay PMTM (methylphenidate extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in individuals 6 years of age and older. Source: FDA website
New Formulation 08-09-18
Poteligeo
The Food and Drug Administration (FDA) approved Poteligeo® (mogamulizumab-kpkc injection) for the treatment of adults with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. Source: FDA website
New Drug 08-08-18
Panzyga
The Food and Drug Administration (FDA) approved Panzyga® (immune globulin intravenous injection) for the treatment of primary humoral immunodeficiency in individuals 2 years of age and older and chronic immune thrombocytopenic purpura in adults. Source: FDA website
New Formulation 08-02-18
Arakoda
The Food and Drug Administration (FDA) approved ArakodaTM (tafenoquine tablets) for the prevention of malaria in people age 18 years old and older. Source: FDA website
New Drug 08-08-18
Annovera
The Food and Drug Administration (FDA) approved AnnoveraTM (segesterone acetate/ethinyl estradiol vaginal system) for the prevention of pregnancy. Source: FDA website
New Drug 08-10-18
Onpattro
The Food and Drug Administration (FDA) approved OnpattroTM (patisiran infusion) for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adults. Source: FDA website
New Drug 08-10-18
Galafold
The Food and Drug Administration (FDA) approved Galafold® (migalastat capsules) for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data. Source: FDA website
New Drug 08-10-18
Levothyroxine and Liothyronine
Westminster Pharmaceuticals announced a voluntary recall of all lots within expiration of levothyroxine and liothyronine tablets due to risk of adulteration. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls/ucm616601.htm Source: FDA website
Drug Recall 08-09-18
Product Quest Manufacturing
Product Quest Manufacturing announced a voluntary recall of one lot of CVS Health 12 Hour Sinus Relief Nasal Mist due to microbiological contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls/ucm616189.htm Source: FDA website
Drug Recall 08-08-18
Valsartan containing products
The Food and Drug Administration (FDA) updated the list of valsartan products under recall to include products manufactured by Hetero Labs Limited labeled as Camber Pharmaceuticals. Contact your healthcare provider with questions. More details and a list of affected products may be viewed at: https://www.fda.gov/drugs/drugsafety/ucm613916.htm Source: FDA website
Drug Recall 08-10-18
Dexycu
The Food and Drug Administration (FDA) approved Dexycu® (dexamethasone intraocular suspension injection) for the treatment of inflammation associated with cataract surgery. Source: FDA website
New Drug 02-12-18
Azedra
The Food and Drug Administration (FDA) approved Azedra® (iobenguane I 131 injection) for the treatment of individuals12 years old and older with iobenguane scan-positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic anticancer therapy. Source: FDA website
New Drug 07-30-18
Mulpleta
The Food and Drug Administration (FDA) approved Mulpleta® (lusutrombopag tablets) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. Source: FDA website
New Drug 07-31-18
Zithromax, Zmax
The antibiotic Zithromax®, Zmax® (azithromycin) should not be given long-term to prevent a certain inflammatory lung condition in individuals with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these individuals. The Food and Drug Administration (FDA) are reviewing additional data and will communicate when their review is done. Contact your healthcare provider with questions. More details may be viewed at:https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm615738.htm Source: FDA website
Drug Warning 08-03-18
Piperacillin and tazobactam
AuroMedics Pharma announced a voluntary recall on piperacillin and tazobactam for injection 3.375 grams per vial due to the presence of particulates identified as glass and silicone material. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/safety/recalls/ucm615383.htm Source: FDA website
Drug Recall 01-08-18
Vonvendi
The Food and Drug Administration (FDA) approved Vonvendi® (von Willebrand factor, recombinant, injection) for the treatment of perioperative management of bleeding in adults with von Willebrand disease. Source: FDA website
New Indication 04-17-18
Tagrisso
The Food and Drug Administration (FDA) approved Tagrisso® (osimertinib tablets) for first-line treatment of individuals with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations, (exon 19 deletions or exon 21 L858R mutations), as detected by a FDA-approved test. Source: FDA website
New Indication 04-18-18
Opdivo and Yervoy
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) and Yervoy® (ipilimumab injection) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma. Source: FDA website
New Indication 04-16-18
Akynzeo
The Food and Drug Administration (FDA) approved Akynzeo® (fosnetupitant/palonosetron injection) for individuals with chemotherapy induced nausea and vomiting. Source: FDA website
New Formulation 04-20-18
Crysvita
The Food and Drug Administration (FDA) approved Crysvita® (burosumab-twza injection) for the treatment of X-linked hypophosphatemia (XLH) in adults and children 1 year of age and older. Source: FDA website
New Drug 04-17-18
Tavalisse
The Food and Drug Administration (FDA) approved TavalisseTM (fostamatinib disodium hexahydrate tablets) for the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. Source: FDA website
New Drug 04-17-18
Dexycu
The Food and Drug Administration (FDA) approved Dexycu® (dexamethasone intraocular suspension injection) for the treatment of inflammation associated with cataract surgery. Source: FDA website
New Drug 02-12-18
Imfinzi
The Food and Drug Administration (FDA) approved Imfinzi® (durvalumab injection) for the treatment of individuals with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed and whose cancer has not progressed after treatment with chemotherapy and radiation. Source: FDA website
New Indication 02-16-18
Luzu
The Food and Drug Administration (FDA) approved Luzu® (luliconazole topical cream) for the treatment of tinea pedis, tinea cruris, and tinea corporis in individuals 12 years and older. Source: FDA website
New Indication 02-23-18
Verzenio
The Food and Drug Administration (FDA) approved Verzenio&tarde; (abemaciclib tablets) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced or metastatic breast cancer. Source: FDA website
New Indication 02-26-18
Otiprio
The Food and Drug Administration (FDA) approved Otiprio® (ciprofloxacin otic suspension) for the treatment of acute otitis externa (AOE) in patients 6 months old and older due to Pseudomonas aeruginosa and Staphylococcus aureus. Source: FDA website
New Indication 03-02-18
Osmolex ER
The Food and Drug Administration (FDA) approved Osmolex ER™ (amantadine extended-release tablets) for the treatment of Parkinson's disease and drug-induced extrapyramidal reactions in adults. Source: FDA website
New Drug 02-19-18
Apadaz
The Food and Drug Administration (FDA) approved Apadaz™ (benzhydrocodone/acetaminophen tablets) for the short-term (14 or fewer days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Source: FDA website
New Drug 02-23-18
ZTlido
The Food and Drug Administration (FDA) approved ZTlido&tarde; (lidocaine topical system) for the relief of pain associated with post-herpetic neuralgia (PHN). Source: FA website
New Drug 02-28-18
Cimduo
The Food and Drug Administration (FDA) approved Cimduo&tarde; (lamivudine/tenofovir disoproxil fumarate tablets) in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adult and pediatric individuals weighing at least 35 kg. Source: FDA website
New Drug 02-28-18
Biaxin
The Food and Drug Administration (FDA) is advising caution before prescribing the antibiotic Biaxin®(clarithromycin) to individuals with heart disease due to a potential increased risk of heart problems or death that can occur years later. A new warning has been added to the label. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm597862.htm Source: FDA website
Drug Warning 02-22-18
Symdeko
The Food and Drug Administration (FDA) approved SymdekoTM (tezacaftor/ivacaftor) for the treatment of individuals with cystic fibrosis (CF) who are at least 12 years old and who are either homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence. Source: FDA website
New Drug 02-12-18
Erleada
The Food and Drug Administration (FDA) approved ErleadaTM (apalutamide tablets) for the treatment of non-metastatic castration-resistant prostate cancer (CRPC). Source: FDA website
New Drug 02-14-18
Acyclovir
Apace Packaging announced a voluntary recall of one lot of acyclovir 400 mg tablets due to product mix-up. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm596590.htm Source: FDA website
Drug Recall 02-14-18
Clopidogrel
International Laboratories announced a voluntary recall of one lot of clopidogrel tablets 75 mg due to mislabeling. Contact your health care provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm592047.htm Source: FDA website
Drug Recall 01-10-18
Balcoltra
The Food and Drug Administration (FDA) approved BalcoltraTM (levonorgestrel/ethinyl estradiol/ferrous bisglycinate tablets) for the prevention of pregnancy. Source: FDA website
New Drug 01-17-18
Trisenox
The Food and Drug Administration (FDA) approved Trisenox® (arsenic trioxide injection) in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. Source: FDA website
New Indication 01-15-18
Gilotrif
The Food and Drug Administration (FDA) approved Gilotrif® (afatinib tablets) in first-line treatment of individuals with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.Source: FDA website
New Indication 01-12-18
Fluarix Quadrivalent
The Food and Drug Administration (FDA) approved Fluarix® Quadrivalent (quadrivalent inactivated split virus influenza vaccine injection) to include use in individuals aged 6 months and older for active immunization against influenza A subtype viruses and type B viruses. Source: FDA website
New Indication 01-12-18
Lynparza
The Food and Drug Administration (FDA) approved Lynparza® (olaparib tablets) for the treatment of individuals with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer who have been treated with chemotherapy either in the neoadjuvant, adjuvant, or metastatic setting. Source: FDA website
New Indication 01-12-18
Isentress
The Food and Drug Administration (FDA) approved Isentress® (raltegravir oral) to include treatment of human immunodeficiency virus (HIV) exposed full-term newborns who weigh at least 2 kg and are up to 4 weeks of age. Source: FDA website
New Indication 11-27-17
Auvi-Q
The Food and Drug Administration (FDA) approved Auvi-Q® (epinephrine 0.1 mg auto-injector) for treating life-threatening allergic reactions, including anaphylaxis, in infants and small children weighing 16.5-33 lbs. who are at risk for or have a history of serious allergic reactions. Source: FDA website
New Indication 11-20-17
Juluca
The Food and Drug Administration (FDA) approved Juluca® (dolutegravir/rilpivirine tablets) as treatment regimen for certain adults with human immunodeficiency virus (HIV)-1 infection. Source: FDA website
New Drug 11-21-17
Clenpiq
The Food and Drug Administration (FDA) approved ClenpiqTM (sodium picosulfate/magnesium oxide/anhydrous citric acid ready-to-drink oral solution) for cleansing of the colon in adults undergoing a colonoscopy. Source: FDA website
New Drug 11-29-17
Sublocade
The Food and Drug Administration (FDA) approved SublocadeTM (buprenorphine extended-release monthly subcutaneous injection) for the treatment of moderate-to-severe opioid use disorder in adults who have initiated treatment with a transmucosal buprenorphine-containing product. Source: FDA website
New Drug 11-30-17
Limbrel
The Food and Drug Administration (FDA) is investigating serious adverse events involving Limbrel® (flavocoxid capsules) currently being marketed as a medical food to manage the metabolic processes associated with osteoarthritis. Reports of adverse events include drug-induced liver injury and hypersensitivity pneumonitis which are potentially life-threatening. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586111.htm Source: FDA website
Drug Warning 11-21-17
Biotin
The Food and Drug Administration (FDA) is alerting health care providers and consumers that biotin (vitamin B7) can significantly interfere with certain lab tests. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586641.htm Source: FDA website
Drug Warning 11-28-17
Riomet
Sun Pharmaceuticals announced a recall of two lots of Riomet® (metformin oral solution) due to contamination with Scopulariopsis brevicaulis. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586510.htm Source: FDA website
Drug Recall 11-27-17
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for previously treated individuals with recurrent locally advanced or metastatic gastric or gastroesophageal junction cancer whose tumors express PD-L1. Source: FDA website
New Indication 09-22-17
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the treatment of hepatocellular carcinoma previously treated with sorafenib. Source: FDA website
New Indication 09-22-17
Genvoya
The Food and Drug Administration (FDA) approved Genvoya® (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide tablets) for use in children with human immunodeficiency virus (HIV) weighing at least 25 kg. Source: FDA website
New Indication 09-27-17
Fiasp
The Food and Drug Administration (FDA) approved Fiasp® (insulin aspart rapidly-acting injection) to improve glycemic control in adults with type 1 and type 2 diabetes. Source: FDA website
New Drug 09-29-17
Verzenio
The Food and Drug Administration (FDA) approved VerzenioTM (abemaciclib tablets) for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after endocrine therapy. Source: FDA website
New Drug 09-28-17
Tracleer
The Food and Drug Administration (FDA) approved Tracleer® (bosentan tablets) for use in children 3 years and older with idiopathic or congenital pulmonary arterial hypertension (PAH), to improve pulmonary vascular resistance, which is expected to result in an improvement in exercise ability. Source: FDA website
New Indication 09-06-17
Durolane
The Food and Drug Administration (FDA) approved Durolane® (hyaluronic acid injection) for the treatment of pain associated with knee osteoarthritis. It is a single-injection therapy. Source: FDA website
New Drug 09-05-17
Mylotarg
The Food and Drug Administration (FDA) approved MylotargTM (gemtuzumab ozogamicin injection) for the treatment of CD33-positive acute myeloid leukemia (AML) in newly-diagnosed adults, and refractory or relapsed AML in adults and children 2 years of age and older. Source: FDA website
New Drug 09-01-17
Foshan Flying Medical Products
The Food and Drug Administration (FDA) is alerting healthcare providers and consumers not to use alcohol pads or benzalkonium chloride antiseptic towelettes made by Foshan Flying Medical Products located in China due to a lack of sterility assurance and other quality issues. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm574576.htm
Source: FDA website
Drug Warning 09-01-17
Victoza
The Food and Drug Administration (FDA) approved Victoza® (liraglutide injection) for the reduction of risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease. Source: FDA website
New Indication 08-25-17
Faslodex
The Food and Drug Administration (FDA) approved Faslodex® (fulvestrant injection) as monotherapy for expanded use in women with hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, who have gone through menopause and have not received previous endocrine therapy. Source: FDA website
New Indication 08-28-17
Actemra
The Food and Drug Administration (FDA) approved Actemra® (tocilizumab injection) for the treatment of chimeric antigen receptor T cell (CAR-T) therapy cell-induced severe or life-threatening cytokine release syndrome (CRS) in individuals 2 years of age and older. Source: FDA website
New Indication 08-30-17
Austedo
The Food and Drug Administration (FDA) approved AustedoTM (deutetrabenazine tablets) for the treatment of tardive dyskinesia in adults. Source: FDA website
New Indication 08-30-17
Duzallo
The Food and Drug Administration (FDA) approved Duzallo® (lesinurad/allopurinol tablets) for the treatment of hyperuricemia associated with gout in individuals who have not achieved target serum uric acid levels with a medically appropriate daily dose of allopurinol alone. Source: FDA website
New Drug 08-21-17
Gocovri
The Food and Drug Administration (FDA) approved GocovriTM (amantadine extended-release capsules) for the treatment of dyskinesia in individuals with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Source: FDA website
New Drug 08-24-17
Vabomere
The Food and Drug Administration (FDA) approved VabomereTM (meropenem/vaborbactam injection) for adults with complicated urinary tract infections (cUTIs). Source: FDA website
New Drug 08-29-17
Benznidazole
The Food and Drug Administration (FDA) approved Benznidazole tablets for Chagas disease in children 2 to 12 years old. Source: FDA website
New Drug 08-29-17
KedRAB
The Food and Drug Administration (FDA) approved KedRABTM (rabies immunoglobulin human injection) for passive, transient post-exposure prophylaxis of rabies infection. Source: FDA website
New Drug 08-25-17
Kymriah
The Food and Drug Administration (FDA) approved KymriahTM (tisagenlecleucel injection) for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in individuals up to 25 years old. Source: FDA website
New Drug 08-30-17
Ninjacof and Ninjacof A
Centurion Labs announced a voluntary recall of one lot of NinjacofTM (chlophedianol/pyrilamine maleate oral liquid) and one lot of NinjacofTM A (acetaminophen/ chlophedianol/pyrilamine maleate oral liquid) due to potential contamination with Burkholderia cepacia. These products are used to temporarily relieve symptoms due to the common cold, allergic rhinitis, or other respiratory allergies. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm572909.htm
Source: FDA website
Drug Recall 08-23-17
Lynparza
The Food and Drug Administration (FDA) approved Lynparza® (olaparib tablets) for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. Source: FDA website
New Indication 08-17-17
Besponsa
The Food and Drug Administration (FDA) approved Besponsa® (inotuzumab ozogamicin injection) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Source: FDA website
New Drug 08-17-17
Pravastatin
International Laboratories announced a voluntary recall of one lot of pravastatin sodium 40 mg tablets due to mislabeling. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm571066.htm. Source: FDA website
Drug Recall 08-10-17
Lorazepam
Amneal Pharmaceuticals announced a voluntary recall of 13 lots of lorazepam oral concentrate 2 mg/mL due to misprinted dosing droppers. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm571796.htm. Source: FDA website
Drug Recall 08-16-17
PharmaTech
The distribution firms Leader brand, Major Pharmaceuticals, and Rugby Laboratories announced a voluntary recall of all lots within expiry of all liquid products manufactured by PharmaTech at its facility in Davie, Fla due to possible product contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm570997.htm. Source: FDA website
Drug Recall 08-10-17
Vectibix
The Food and Drug Administration (FDA) approved Vectibix® (panitumumab injection) for individuals with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC) as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy. Source: FDA website
New Indication 06-29-17
Orencia
The Food and Drug Administration (FDA) approved Orencia® (abatacept injection) for the treatment of active psoriatic arthritis (PsA) in adults. Source: FDA website
New Indication 07-06-17
Triptodur
The Food and Drug Administration (FDA) approved TriptodurTM (triptorelin injection) for the treatment of individuals 2 years of age and older with central precocious puberty (CPP). Dosing is once every 6 months. Source: FDA website
New Drug 06-30-17
Fibryna
The Food and Drug Administration (FDA) approved Fibryna® (fibrinogen, human, concentrate injection) for the treatment of acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. Source: FDA website
New Drug 06-07-17
Endari
The Food and Drug Administration (FDA) approved EndariTM (L-glutamine oral powder) to reduce the acute complications of sickle cell disease in adult and pediatric individuals 5 years and older. Source: FDA website
New Drug 07-07-17
NovoPen Echo Insulin Delivery Device
Novo Nordisk announced a recall of insulin cartridge holders used in a small number of NovoPen Echo batches because they may crack or break if exposed to certain chemicals. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm565955.htm Source: FDA website
Drug Recall 07-06-17
Zykadia
The Food and Drug Administration (FDA) approved Zykadia® (ceritinib capsules) for use in first-line anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC). Source: FDA website
New Indication 05-26-17
Zerviate
The Food and Drug Administration (FDA) approved ZerviateTM (cetirizine ophthalmic solution) for the treatment of ocular itching associated with allergic conjunctivitis. Source: FDA website
New Drug 06-01-17
Isentress HD
The Food and Drug Administration (FDA) approved Isentress® HD (raltegravir tablets) for use in combination with other antiretroviral drugs for the treatment of human immunodeficiency virus (HIV)-1 infection in adults and pediatric individuals (weighing 40 kg or more) who are treatment-naive or whose virus has been suppressed on an initial regimen of Isentress 400 mg twice daily. Source: FDA website
New Drug 05-30-17
Rebinyn
The Food and Drug Administration (FDA) approved Rebinyn® (nonacog beta pegol injection) for the treatment of individuals with hemophilia B. Source: FDA website
New Drug 06-01-17
Mibela 24 FE
Lupin Pharmaceuticals announced a recall of one lot of Mibela 24 FE (norethindrone acetate/ethinyl estradiol chewable tablets and ferrous fumarate tablets) due to out of sequence tablets and missing expiration date and lot information. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm560908.htm Source: FDA website
Drug Recall 05-29-17
Bavencio
The Food and Drug Administration (FDA) approved Bavencio® (avelumab injection) for individuals with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Source: FDA website
New Indication 05-09-17
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination with pemetrexed and carboplatin for the first-line treatment of metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression. Source: FDA website
New Indication 05-10-17
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for individuals with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Source: FDA website
New Indication 05-18-17
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for individuals with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. Source: FDA website
New Indication 05-18-17
Kalydeco
The Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor tablets and oral granules) for use in individuals with cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Source: FDA website
New Indication 05-18-17
Minolira
The Food and Drug Administration (FDA) approved MinoliraTM (minocycline extended-release tablets) for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in individuals aged 12 years and older. Source: FDA website
New Drug 05-10-17
Canagliflozin
The Food and Drug Administration (FDA) has concluded that the type 2 diabetes medication canagliflozin (Invokana®, Invokamet®, and Invokamet® XR) causes an increased risk of leg and foot amputations. New warnings, including a Boxed Warning, will be added to canagliflozin drug labels. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm558605.htm Source: FDA website
Drug Warning 05-16-17
Trulicity
The Food and Drug Administration (FDA) approved Trulicity® (dulaglutide injection) for use in combination with basal insulin for adults with type 2 diabetes. Source: FDA website
New Indication 02-08-17
Spiriva Respimat
The Food and Drug Administration (FDA) approved Spiriva® Respimat® (tiotropium bromide oral inhalation spray) for the long-term maintenance treatment of asthma in individuals as young as 6 years old. Source: FDA website
New Indication 02-16-17
Gammaplex
The Food and Drug Administration (FDA) approved Gammaplex® 10% (immune globulin intravenous, human, 10% liquid) for the treatment of primary immunodeficiency (PI) and chronic immune thrombocytopenic purpura (ITP) in adults. Source: FDA website
New Drug 02-07-17
Tirosint-SOL
The Food and Drug Administration (FDA) approved Tirosint-SOLTM (levothyroxine sodium oral solution) for the treatment of hypothyroidism and thyroid stimulating hormone suppression in the management of some thyroid cancers. Source: FDA website
New Drug 02-15-17
Siliq
The Food and Drug Administration (FDA) approved SiliqTM (brodalumab injection) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and who have failed to respond or have lost response to other systemic therapies. Source: FDA website
New Drug 02-15-17
Parsabiv
The Food and Drug Administration (FDA) approved ParsabivTM (etelcalcetide injection for intravenous use) for treatment of secondary hyperparathyroidism (SHPT) in adults with chronic kidney disease (CKD) on hemodialysis. Source: FDA website
New Drug 02-07-17
Emflaza
The Food and Drug Administration (FDA) approved EmflazaTM (deflazacort tablets and oral suspension) for treatment of Duchenne muscular dystrophy (DMD) in individuals 5 years and older. Source: FDA website
New Drug 02-09-17
Human chorionic gonadotropin
Synergy Rx Pharmacy announced a recall of all lots of human chorionic gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial due to a lack of sterility assurance. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm541722.htm Source: FDA website
Drug Recall 02-15-17
Lucentis
The Food and Drug Administration (FDA) approved Lucentis® (ranibizumab injection) for the treatment of individuals with myopic choroidal neovascularization (mCNV). Source: FDA website
New Indication 01-06-17
Arymo ER
The Food and Drug Administration (FDA) approved Arymo ™ ER (morphine sulfate extended-release tablets) for pain severe enough to require daily, around-the-clock, long-acting treatment for which other options are inadequate. Source: FDA website
New Drug 01-09-17
Saphris
The Food and Drug Administration (FDA) approved Saphris® (asenapine tablets) for use as maintenance monotherapy treatment in adults with bipolar disorder. Source: FDA website
New Indication 01-18-17
Imbruvica
The Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib capsules) for the treatment of individuals with marginal zone lymphoma (MZL) who require systemic therapy and have received one or more prior anti-CD20-based therapy. Source: FDA website
New Indication 01-19-17
Vantrela ER
The Food and Drug Administration (FDA) approved Vantrela™ ER (hydrocodone bitartrate extended-release tablets) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Source: FDA website
New Drug 01-18-17
Rhofade
The Food and Drug Administration (FDA) approved Rhofade™ (oxymetazoline topical cream) for the treatment of persistent facial erythema associated with rosacea in adults. Source: FDA website
New Drug 01-19-17
Trulance
The Food and Drug Administration (FDA) approved Trulance™ (plecanatide tablets) for the treatment of chronic idiopathic constipation (CIC) in adults. Source: FDA website
New Drug 01-19-17
Latuda
The Food and Drug Administration (FDA) approved Latuda® (lurasidone tablets) for the treatment of schizophrenia in adolescents aged 13-17 years. Source: FDA website
New Indication 01-30-17
Symbicort
The Food and Drug Administration (FDA) approved Symbicort® (budesonide/formoterol fumarate dihydrate oral inhalation) for the treatment of asthma in pediatric individuals aged 6 to 12 years. Source: FDA website
New Indication 01-30-17
Stribild
The Food and Drug Administration (FDA) approved Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate tablets) for human immunodeficiency virus (HIV)-1 infection in pediatric individuals 12 years and older and weighing 35 kg or more. Source: FDA website
New Indication 01-31-17
Ofirmev
The Food and Drug Administration (FDA) approved Ofirmev® (acetaminophen injection) to include recommended dosing for treatment of fever in neonates (including premature neonates born 32 or more weeks gestational age) up to 28 days chronological age and for infants aged 29 days to 2 years. Source: FDA website
New Indication 02-01-17
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the treatment of individuals with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy. Source: FDA website
New Indication 02-02-17
AirDuo RespiClick
The Food and Drug Administration (FDA) approved AirDuo™ RespiClick® (fluticasone propionate/salmeterol oral inhalation powder) for the treatment of asthma in individuals 12 years and older. Source: FDA website
New Drug 03-30-17
ArmonAir RespiClick
The Food and Drug Administration (FDA) approved ArmonAir™ RespiClick® (fluticasone propionate oral inhalation powder) as maintenance treatment of asthma as prophylactic therapy in individuals 12 years and older. Source: FDA website
New Drug 03-30-17
Chlorhexidine gluconate
The Food and Drug Administration (FDA) is warning that rare but serious allergic reactions have been reported with skin antiseptic products containing chlorhexidine gluconate. Contact your healthcare provider with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm539575.htm Source: FDA website
Drug Warning 02-02-17
Revlimid
The Food and Drug Administration (FDA) approved Revlimid® (lenalidomide capsules) as maintenance treatment for individuals with multiple myeloma following autologous hematopoietic stem cell transplant (Auto-HSCT). Source: FDA website
New Indication 02-22-17
Technivie
The Food and Drug Administration (FDA) approved Technivie™ (ombitasvir/paritaprevir/ritonavir tablets) for individuals with genotype 4 chronic hepatitis C infection (HCV) with compensated cirrhosis. Source: FDA website
New Indication 02-27-17
Qtern
The Food and Drug Administration (FDA) approved Qtern® (dapagliflozin/saxagliptin tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who have inadequate control with dapagliflozin 10 mg or who are already treated with dapagliflozin and saxagliptin. Source: FDA website
New Drug 02-28-17
Xermelo
The Food and Drug Administration (FDA) approved Xermelo™ (telotristat ethyl tablets) for the treatment of carcinoid syndrome diarrhea in combination with a somatostatin analog when symptoms are not adequately controlled with a somatostatin analog alone. Source: FDA website
New Drug 02-28-17
Odactra
The Food and Drug Administration (FDA) approved Odactra (house dust mite allergen extract sublingual tablets) for the treatment of house dust mite-induced allergic rhinitis in adults. Source: FDA website
New Drug 03-01-17
Edex
Endo Pharmaceuticals announced a recall of one lot of Edex® (alprostadil 10 mcg for injection) due to the potential lack of sterility assurance. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm543526.htm Source: FDA website
Drug Recall 02-27-17
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for children and adults who have classical Hodgkin lymphoma (cHL) that has resisted treatment or relapsed after three or more prior lines of therapy. Source: FDA website
New Indication 03-14-17
Noctiva
The Food and Drug Administration (FDA) approved Noctiva™ (desmopressin acetate nasal spray) for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least twice per night to void. Source: FDA website
New Drug 03-03-17
Nipride RTU
The Food and Drug Administration (FDA) approved Nipride RTU (sodium nitroprusside ready to use injection) for the immediate reduction of blood pressure. It is also approved for producing controlled hypotension to reduce bleeding during surgery and for the treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure peripheral vascular resistance and mean arterial blood pressure. Source: FDA website
New Drug 03-08-17
Symproic
The Food and Drug Administration (FDA) approved Symproic® (naldemedine tablets) for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Source: FDA website
New Drug 03-23-17
Kisqali
The Food and Drug Administration (FDA) approved Kisqali® (ribociclib tablets) as initial endocrine-based treatment of postmenopausal women with HR+/HER2− advanced or metastatic breast cancer used with an aromatase inhibitor. Source: FDA website
New Drug 03-13-17
Xadago
The Food and Drug Administration (FDA) approved Xadago® (safinamide tablets) for the treatment of Parkinson's disease as add-on therapy to levodopa/carbidopa. Source: FDA website
New Drug 03-21-17
Bavencio
The Food and Drug Administration (FDA) approved Bavencio® (avelumab injection) for treatment of adult and pediatric individuals 12 years and older with metastatic Merkel cell carcinoma (MCC). Source: FDA website
New Drug 03-23-17
Viberzi
The Food and Drug Administration (FDA) is warning that Viberzi® (eluxadoline tablets), a medication used to treat irritable bowel syndrome with diarrhea (IBS-D), should not be used in individuals who do not have a gallbladder due to an increased risk of developing serious pancreatitis. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm546771.htm Source: FDA website
Drug Warning 03-15-17
Qudexy XR
The Food and Drug Administration (FDA) approved Qudexy® XR (topiramate extended-release capsules) for use as prophylaxis of migraine headaches in adults and children aged 12 years and older. Source: FDA website
New Indication 03-30-17
Humira
The Food and Drug Administration (FDA) approved Humira® (adalimumab injection) labeling to include the addition of moderate to severe fingernail psoriasis data for individuals with moderate to severe chronic plaque psoriasis. Source: FDA website
New Indication 03-30-17
Dupixent
The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) for the treatment of adults with moderate to severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Source: FDA website
New Drug 03-28-17
Ocrevus
The Food and Drug Administration (FDA) approved Ocrevus™ (ocrelizumab injection) for the treatment of individuals with relapsing or primary progressive forms of multiple sclerosis. Source: FDA website
New Drug 03-28-17
Zejula
The Food and Drug Administration (FDA) approved Zejula™ (niraparib capsules) for the maintenance treatment of adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy. Source: FDA website
New Drug 03-27-17
Ibrance
The Food and Drug Administration (FDA) approved Ibrance® (palbociclib capsules) for use with any aromatase inhibitor as initial endocrine-based therapy in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. Source: FDA website
New Indication 03-31-17
Austedo
The Food and Drug Administration (FDA) approved Austedo™ (deutetrabenazine tablets) for the treatment of chorea associated with Huntington's disease (HD). Source: FDA website
New Drug 04-03-17
EpiPen/EpiPen Jr
Mylan announced a voluntary recall of select lots of EpiPen® and EpiPen Jr® (epinephrine auto-injector) due to failure of device to activate. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm550165.htm Source: FDA website
Drug Recall 03-31-17
Trokendi XR
The Food and Drug Administration (FDA) approved Trokendi XR® (topiramate extended-release capsules) for prophylaxis of migraine headache in individuals 12 years of age and older. Source: FDA website
New Indication 04-06-17
Sovaldi
The Food and Drug Administration (FDA) approved Sovaldi® (sofosbuvir tablets) to treat hepatitis C virus (HCV) in children ages 12 to 17. Source: FDA website
New Indication 04-07-17
Harvoni
The Food and Drug Administration (FDA) approved Harvoni® (ledipasvir/sofosbuvir tablets) to treat hepatitis C virus (HCV) in children ages 12 to 17. Source: FDA website
New Indication 04-07-17
Tecentriq
The Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab injection) for the treatment of individuals with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy. Source: FDA website
New Indication 04-17-17
Lucentis
The Food and Drug Administration (FDA) approved Lucentis® (ranibizumab injection) to treat diabetic retinopathy in individuals with or without diabetic macular edema (DME). Source: FDA website
New Indication 04-17-17
Ingrezza
The Food and Drug Administration (FDA) approved Ingrezza™ (valbenazine capsules) for the treatment of tardive dyskinesia in adults. Source: FDA website
New Drug 04-17-17
Homeopathic teething products
The Food and Drug Administration (FDA) announced a voluntary recall of all lots of Hyland’s Baby and Hyland’s Baby Nighttime teething tablets made by Standard Homeopathic Company due to confirmed levels of belladonna. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm538687.htm Source: FDA website
Drug Recall 04-14-17
Phenobarbital
C.O. Truxton announced a voluntary recall of one lot of Phenobarbital 15 mg tablets due to a labeling error on declared strength. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm554358.htm Source: FDA website
Drug Recall 04-21-17
Isomeric Pharmacy Solutions
Isomeric Pharmacy Solutions announced a voluntary recall of all lots of unexpired sterile products due to concerns of a lack of sterility assurance. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm551299.htm Source: FDA website
Drug Recall 04-06-17
Thymoglobulin
The Food and Drug Administration (FDA) approved Thymoglobulin® (anti-thymocyte globulin, [rabbit] injection) for use with concomitant immunosuppression in the prophylaxis of acute rejection in individuals receiving a kidney transplant. Source: FDA website
New Indication 04-24-17
Stivarga
The Food and Drug Administration (FDA) approved Stivarga® (regorafenib tablets) for the treatment of individuals with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Source: FDA website
New Indication 04-27-17
Xatmep
The Food and Drug Administration (FDA) approved Xatmep™ (methotrexate oral solution) for the treatment of acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA) in pediatric individuals. Source: FDA website
New Drug 04-26-17
RoxyBond
The Food and Drug Administration (FDA) approved RoxyBond™ (oxycodone tablets) for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Source: FDA website
New Drug 04-26-17
Brineura
The Food and Drug Administration (FDA) approved Brineura™ (cerliponase alfa injection for intraventricular use) as a treatment to slow loss of ability to walk or crawl in symptomatic pediatric individuals 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2). Source: FDA website
New Drug 04-27-17
Rydapt
The Food and Drug Administration (FDA) approved Rydapt® (midostaurin capsules) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) who are FMLT3 mutation-positive (FLT3+) as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. Source: FDA website
New Drug 04-28-17
Illegal cancer treatments
The Food and Drug Administration (FDA) issued warning letters addressed to 14 U.S. based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat, or cure cancer. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm554777.htm Source: FDA website
Drug Warning 04-25-17
Bunavail
The Food and Drug Administration (FDA) approved Bunavail® (buprenorphine/naloxone buccal film) for the induction of opioid addiction treatment. Source: FDA website
New Indication 05-02-17
Alunbrig
The Food and Drug Administration (FDA) approved Alunbrig™ (brigatinib tablets) for the treatment of individuals with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Source: FDA website
New Drug 04-28-17
Tymlos
The Food and Drug Administration (FDA) approved Tymlos™ (abaloparatide subcutaneous injection) for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or individuals who have failed or are intolerant to other available osteoporosis therapy. Source: FDA website
New Drug 04-28-17
Imfinzi
The Food and Drug Administration (FDA) approved Imfinzi™ (durvalumab injection) for the treatment of individuals with locally advanced or metastatic urothelial carcinoma who have disease progression during or followng platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Source: FDA website
New Drug 05-01-17
Radicava
The Food and Drug Administration (FDA) approved Radicava™ (edaravone injection) to treat individuals with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig's disease. Source: FDA website
New Drug 05-05-17
Jadenu Sprinkle
The Food and Drug Administration (FDA) approved Jadenu® Sprinkle (deferasirox oral granules) for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in individuals 2 years of age and older and for the treatment of chronic iron overload in individuals 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes and with a liver iron concentration (LIC) of at least 5 milligrams of iron per gram of liver dry weight (mg Fe/g dw) and a serum ferritin greater than 300 mcg/L. Source: FDA website
New Drug 05-18-17
Kevzara
The Food and Drug Administration (FDA) approved Kevzara® (sarilumab injection) for the treatment of moderately to severely active rheumatoid arthritis in adults. Source: FDA website
New Drug 05-22-17
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for adult and pediatric individuals with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Source: FDA website
New Indication 05-23-17
Actemra
The Food and Drug Administration (FDA) approved Actemra® (tocilizumab injection) for the treatment of adults with giant cell arteritis. Source: FDA website
New Indication 05-22-17
Ravicti
The Food and Drug Administration (FDA) approved Ravicti® (glycerol phenylbutyrate oral liquid) to treat individuals 2 months of age and older who have urea cycle disorders (UCDs) that cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Source: FDA website
New Indication 05-01-17
Brilinta
AstraZeneca announced a voluntary recall of one lot of physician sample bottles containing eight tablets of Brilinta (ticagrelor) 90 mg tablets due to a report of another medicine in one bottle. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm560786.htm Source: FDA website
Drug Recall 05-26-17
Dysport
The Food and Drug Administration (FDA) approved Dysport® (abobotulinumtoxinA injection) for the treatment of lower limb spasticity in adults. Source: FDA website
New Indication 06-16-17
Norvir
The Food and Drug Administration (FDA) approved Norvir® (ritonavir oral powder) for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection in children and adults. Source: FDA website
New Drug 06-08-17
Symjepi
The Food and Drug Administration (FDA) approved Symjepi™ (epinephrine injection) for the emergency treatment of allergic reactions including anaphylaxis. Source: FDA website
New Drug 06-15-17
Topical products by Phillips Company
Phillips Company announced a voluntary recall of all lots of Tetrastem, Diabecline, Tetracycline-ABC, VenomX, Acneen, StaphWash, StringMed, NoPain and LidoMed due to concerns of manufacturing practices. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm563204.htm Source: FDA website
Drug Recall 06-14-17
Paliperidone extended-release
Teva Pharmaceuticals announced a voluntary recall of one lot of paliperidone extended-release tablets 3 mg due to dissolution test failure. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm563358.htm Source: FDA website
Drug Recall 06-15-17
Eliquis
Bristol-Myers Squibb announced a voluntary recall of one lot of Eliquis 5 mg tablets due to customer complaint that a bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm563035.htm Source: FDA website
Drug Recall 06-13-17
Mekinist and Tafinlar
The Food and Drug Administration (FDA) approved Mekinist® (trametinib tablets) and Tafinlar® (dabrafenib capsules) in combination for individuals with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by a Food and Drug Administration (FDA)-approved test. Source: FDA website
New Indication 06-22-17
Darzalex
The Food and Drug Administration (FDA) approved Darzalex® (daratumumab injection) in combination with pomalidomide and dexamethasone for the treatment of individuals with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Source: FDA website
New Indication 06-16-17
Cotempla XR-ODT
The Food and Drug Administration (FDA) approved Cotempla XR-ODT (methylphenidate extended-release orally disintegrating tablets) for the once-daily treatment of children 6-17 years of age with attention-deficit/hyperactivity disorder (ADHD). Source: FDA website
New Drug 06-20-17
Mydayis
The Food and Drug Administration (FDA) approved Mydayis™ (amphetamine mixed salts capsules) as once-daily treatment for ADHD in individuals 13 years of age and older. Source: FDA website
New Drug 06-20-17
Rituxan Hycela
The Food and Drug Administration (FDA) approved Rituxan Hycela™ (rituximab/hyaluronidase injection) for adults with follicular lymphoma, diffuse B-cell lymphoma, and chronic lymphocytic leukemia. Source: FDA website
New Drug 06-22-17
Haegarda
The Food and Drug Administration (FDA) approved Haegarda® (C1 esterase inhibitor subcutaneous injection) for the prevention of hereditary angioedema (HAE) attacks in adolescents and adults. Source: FDA website
New Drug 06-22-17
Baxdela
The Food and Drug Administration (FDA) approved Baxdela™ (delafloxacin tablets and injection for intravenous use) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria. Source: FDA website
New Drug 06-19-17
Bevyxxa
The Food and Drug Administration (FDA) approved Bevyxxa™ (betrixaban capsules) for the prophylaxis of venous thromboembolism (VTE) in adults hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE. Source: FDA website
New Drug 06-23-17
Blincyto
The Food and Drug Administration (FDA) approved Blinctyo® (blinatumomab injection) for the treatment of individuals with Philadelphia chromosome-positive (Ph+) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Source: FDA website
New Indication 07-11-17
Zypitamag
The Food and Drug Administration (FDA) approved Zypitamag™ (pitavastatin tablets) for the treatment of primary or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (ApoB), triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C). Source: FDA website
New Drug 07-18-17
Nerlynx
The Food and Drug Administration (FDA) approved Nerlynx™ (neratinib tablets) for the extended adjuvant treatment of adults with early stage HER2-overexpressed/amplified breast cancer, to follow trastuzumab-based therapy. Source: FDA website
New Drug 07-17-17
Vosevi
The Food and Drug Administration (FDA) approved Vosevi™ (sofosbuvir/velpatasvir/voxilaprevir tablets) for the retreatment of adults with chronic hepatitis C virus (HCV) genotypes 1–6 without cirrhosis or with mild cirrhosis who were previously treated with an NS5A inhibitor-containing regimen or in adults with genotype 1a or 3 who were previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor. Source: FDA website
New Drug 07-18-17
Tremfya
The Food and Drug Administration (FDA) approved Tremfya™ (guselkumab injection) for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Source: FDA website
New Drug 07-13-17
Fycompa
The Food and Drug Administration (FDA) approved Fycompa® (perampanel tablets) as monotherapy use for the treatment of partial-onset seizures with or without secondarily generalized seizures in individuals with epilepsy 12 years of age and older. Source: FDA website
New Indication 07-27-17
Yervoy
The Food and Drug Administration (FDA) approved Yervoy® (ipilimumab injection) to include treatment of unresectable or metastatic melanoma in individuals 12 years of age and older. Source: FDA website
New Indication 07-24-17
Relizorb
The Food and Drug Administration (FDA) approved Relizorb® (immobilized lipase digestive enzyme cartridge) for use in individuals 5 years of age and older with fat malabsorption. Source: FDA website
New Indication 07-20-17
Abilify Maintena
The Food and Drug Administration (FDA) approved Abilify Maintena® (aripiprazole extended-release injectable suspension) for the maintenance monotherapy treatment of bipolar I disorder in adults. Source: FDA website
New Indication 07-28-17
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the treatment of individuals 12 years of age and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Source: FDA website
New Indication 08-01-17
Kalydeco
The Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor tablets and oral granules) for use in individuals with cystic fibrosis (CF) who are 2 years of age and older and have 1 of 5 residual function mutations that results in a splicing defect in the CF transmembrane conductance regulator (CFTR) gene. Source: FDA website
New Indication 08-01-17
Imbruvica
The Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib capsules) for the treatment of adults with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy. Source: FDA website
New Indication 08-02-17
Epclusa
The Food and Drug Administration (FDA) approved Epclusa® (sofosbuvir/velpatasvir tablets) for the treatment of hepatitis C genotypes 1 through 6 in individuals coinfected with human immunodeficiency virus (HIV). Source: FDA website
New Indication 08-02-17
Benlysta
The Food and Drug Administration (FDA) approved Benlysta® (belimumab subcutaneous injection) for the treatment of adults with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. Source: FDA website
New Drug 07-21-17
Nityr
The Food and Drug Administration (FDA) approved Nityr™ (nitisinone tablets) for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Source: FDA website
New Drug 08-01-17
Vyxeos
The Food and Drug Administration (FDA) approved Vyxeos™ (daunorubicin/cytarabine injection) for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Source: FDA website
New Drug 08-03-17
Idhifa
The Food and Drug Administration (FDA) approved Idhifa® (enasidenib tablets) for the treatment of adults with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test. Source: FDA website
New Drug 08-01-17
Mavyret
The Food and Drug Administration (FDA) approved Mavyret™ (glecaprevir/pibrentasvir tablets) for the treatment of individuals with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis and with compensated cirrhosis (Child-Pugh A). MAVYRET is also indicated for the treatment of adults with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both. Source: FDA website
New Drug 08-03-17
Guardian Pharmacy Services
The Food and Drug Administration (FDA) received reports of adverse events in individuals who were administered intravitreal injections of a drug containing triamcinolone and moxifloxacin compounded by Guardian Pharmacy Services in Dallas, Texas. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm569123.htm Source: FDA website
Drug Warning 07-28-17
Diocto
Rugby Laboratories announced a voluntary recall of Diocto docusate sodium liquid and syrup solutions) manufactured by PharmaTech due to possible product contamination. Contact your healthcare professional with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm570014.htm Source: FDA website
Drug Recall 08-03-17
CaroSpir
The Food and Drug Administration (FDA) approved CaroSpir® (spironolactone oral suspension) for the treatment of heart failure and reduced ejection fraction. Source: FDA website
New Drug 08-07-17
QVAR RediHaler
The Food and Drug Administration (FDA) approved QVAR® RediHalerTM (beclomethasone dipropionate HFA inhalation aerosol) for the maintenance treatment of asthma as a prophylactic therapy in individuals 4 years of age and older Source: FDA website
New Drug 08-07-17
Nikita
The Food and Drug Administration (FDA) approved NikitaTM (pitavastatin tablets) for the treatment of primary hyperlipidemia and mixed dyslipidemia. Source: FDA website
New Drug 08-09-17
PharmaTech
The Food and Drug Administration (FDA) is advising healthcare providers and consumers not to use any liquid product manufactured by PharmaTech and distributed by Rugby Laboratories due to contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm570674.htm Source: FDA website
Drug Warning 08-08-17
Vital Rx
The Food and Drug Administration (FDA) is advising healthcare providers and consumers not to use drug products intended to be sterile that are produced and distributed by Vital Rx, doing business as Atlantic Pharmacy and Compounding, Pompano Beach, Florida due to lack of sterility assurance. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm570944.htm Source: FDA website
Drug Warning 08-10-17
Symbicort
The Food and Drug Administration (FDA) approved Symbicort® (budesonide/formoterol fumarate dihydrate 160/4.5 mcg oral inhalation) to reduce exacerbations of chronic obstructive pulmonary disease (COPD). Source: FDA website
New Indication 09-14-17
Aptiom
The Food and Drug Administration (FDA) approved Aptiom® (eslicarbazepine acetate tablets) to include the treatment of partial-onset seizures in children and adolescents aged 4-17 years. Source: FDA website
New Indication 09-14-17
Afluria Quadrivalent
The Food and Drug Administration (FDA) approved Afluria® Quadrivalent (influenza vaccine injection) for use in individuals 5 years and older for influenza immunization. Source: FDA website
New Indication 09-14-17
Briviact
The Food and Drug Administration (FDA) approved Briviact® (brivaracetam tablets, oral solution, and injection) as monotherapy for partial-onset (focal) seizures in individuals 16 years and older with epilepsy. Source: FDA website
New Indication 09-15-17
Aliqopa
The Food and Drug Administration (FDA) approved Aliqopa™ (copanlisib injection) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments. Source: FDA website
New Drug 09-14-17
Medtronic diabetes infusion sets
Medtronic announced a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps due to a vent membrane that may be susceptible to being blocked by fluid. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm575778.htm Source: FDA website
Drug Recall 09-12-17
Privigen
The Food and Drug Administration (FDA) approved Privigen® (immune globulin intravenous, human, 10% liquid) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP) to improve neuromuscular disability. Source: FDA website
New Indication 09-15-17
Somatuline Depot
The Food and Drug Administration (FDA) approved Somatuline® Depot (lanreotide injection) for the treatment of carcinoid syndrome to reduce the frequency of short-acting somatostatin analog rescue therapy. Source: FDA website
New Indication 09-18-17
Rapivab
The Food and Drug Administration (FDA) approved Rapivab™ (peramivir injection) for use in pediatric individuals 2 years and older with acute uncomplicated influenza who have been symptomatic for no more than 2 days. Source: FDA website
New Indication 09-21-17
Adzenys ER
The Food and Drug Administration (FDA) approved Adzenys ER™ (amphetamine extended-release oral suspension) for the treatment of attention deficit hyperactivity disorder (ADHD) in individuals 6 years of age and older. Source: FDA website
New Drug 09-18-17
Trelegy Ellipta
The Food and Drug Administration (FDA) approved Trelegy® Ellipta® (fluticasone furoate/umeclidinium/vilanterol oral inhalation) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in individuals receiving Breo® Ellipta® (fluticasone furoate/vilanterol) who need additional treatment or individuals receiving Incruse® Ellipta® (umeclidinium) and Breo Ellipta. Source: FDA website
New Drug 09-18-17
Xhance
The Food and Drug Administration (FDA) approved Xhance™ (fluticasone propionate nasal spray) for the treatment of nasal polyps in adults. Xhance uses a new delivery device. Source: FDA website
New Drug 09-19-17
Solosec
The Food and Drug Administration (FDA) approved Solosec™ (secnidazole oral granules) for the single-dose treatment of bacterial vaginosis in adult women. Source: FDA website
New Drug 09-18-17
Botox Cosmetic
The Food and Drug Administration (FDA) approved Botox® Cosmetic (onabotulinumtoxinA injection) for the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults. Source: FDA website
New Indication 10-03-17
Ascor
The Food and Drug Administration (FDA) approved Ascor® (ascorbic acid injection) for the short-term (up to 1 week) treatment of scurvy in adults and children ages 5 months and older for whom oral administration is not possible, insufficient, or contraindicated. Source: FDA website
New Drug 10-04-17
Zilretta
The Food and Drug Administration (FDA) approved Zilretta™ (triamcinolone acetonide extended-release injectable suspension) for osteoarthritis (OA) knee pain. Source: FDA website
New Drug 10-06-17
Lyrica CR
The Food and Drug Administration (FDA) approved Lyrica® CR (pregabalin extended-release tablets) for the management of neuropathic pain associated with diabetic peripheral neuropathy and the management of postherpetic neuralgia. Source: FDA website
New Drug 10-12-17
Stelara
The Food and Drug Administration (FDA) approved Stelara® (ustekinumab injection) for the treatment of adolescents aged 12 and over with moderate to severe plaque psoriasis. Source: FDA website
New Indication 10-16-17
Simponi Aria
The Food and Drug Administration (FDA) approved Simponi Aria® (golimumab injection) for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis. Source: FDA website
New Indication 10-20-17
Soliris
The Food and Drug Administration (FDA) approved Soliris® (eculizumab injection) for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive. Source: FDA website
New Indication 10-23-17
Shingrix
The Food and Drug Administration (FDA) approved Shingrix (zoster vaccine recombinant, adjuvanted injection) for the prevention of shingles (herpes zoster) in adults aged 50 and older. Source: FDA website
New Drug 10-20-17
Bydureon Bcise
The Food and Drug Administration (FDA) approved Bydureon® BCise™ (exenatide extended-release autoinjector) to improve glycemic control in adults with type 2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise. Source: FDA website
New Drug 10-23-17
Varubi
The Food and Drug Administration (FDA) approved Varubi® (rolapitant injection) for use in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including but not limited to, highly emetogenic chemotherapy. Source: FDA website
New Drug 10-25-17
Yescarta
The Food and Drug Administration (FDA) approved Yescarta™ (axicabtagene ciloleucel injection) for the treatment of individuals with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma (NHL) who are ineligible for autologous stem cell transplant. Source: FDA website
New Drug 10-18-17
Vimpat
The Food and Drug Administration (FDA) approved Vimpat® (lacosamide tablets and injection) for the treatment of partial-onset seizures in pediatric individuals ages 4 and older. Source: FDA website
New Indication 11-06-17
Alecensa
The Food and Drug Administration (FDA) approved Alecensa® (alectinib capsules) as a first-line treatment for individuals with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by a Food and Drug Administration (FDA)-approved test. Source: FDA website
New Indication 11-06-17
Auryxia
The Food and Drug Administration (FDA) approved Auryxia® (ferric citrate tablets) for the treatment of iron deficiency anemia in adults with chronic kidney disease (CKD) who are not on dialysis. Source: FDA website
New Indication 11-07-17
Adcetris
The Food and Drug Administration (FDA) approved Adcetris® (brentuximab vedotin injection) for the treatment of adults with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy. Source: FDA website
New Indication 11-09-17
Zelboraf
The Food and Drug Administration (FDA) approved Zelboraf® (vemurafenib tablets) for the treatment of adults with Erdheim-Chester Disease (ECD) with BRAF V600 mutation. Source: FDA website
New Indication 11-06-17
Vyzulta
The Food and Drug Administration (FDA) approved Vyzulta™ (latanoprostene bunod ophthalmic solution) for the reduction of intraocular pressure (IOP) in individuals with open-angle glaucoma or ocular hypertension. Source: FDA website
New Drug 11-02-17
Prevymis
The Food and Drug Administration (FDA) approved Prevymis™ (letermovir tablets and injection) for the prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). Source: FDA website
New Drug 11-08-17
Calquence
The Food and Drug Administration (FDA) approved Calquence® (acalabrutinib capsules) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. Source: FDA website
New Drug 10-31-17
Sprycel
The Food and Drug Administration (FDA) approved Sprycel® (dasatinib tablets) to include the treatment of children with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Source: FDA website
New Indication 11-10-17
Vraylar
The Food and Drug Administration (FDA) approved Vraylar® (cariprazine capsules) for the maintenance treatment of adults with schizophrenia. Source: FDA website
New Indication 11-13-17
Faslodex
The Food and Drug Administration (FDA) approved Faslodex® (fulvestrant injection) in combination with abemaciclib for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer in women with disease progression after endocrine therapy. Source: FDA website
New Indication 11-15-17
Tekturna
The Food and Drug Administration (FDA) approved Tekturna® (aliskiren oral pellets) for the treatment of hypertension in adults and children 6 years of age and older. Source: FDA website
New Indication 11-15-17
Gazyva
The Food and Drug Administration (FDA) approved Gazyva® (obinutuzumab injection) in combination with chemotherapy, followed by Gazyva monotherapy in responders, for individuals with previously untreated follicular lymphoma. Source: FDA website
New Indication 11-16-17
Sutent
The Food and Drug Administration (FDA) approved Sutent® (sunitinib malate capsules) for the adjuvant treatment of adults who are at a high risk of kidney cancer returning after a kidney has been removed. Source: FDA website
New Indication 11-16-17
Cinvanti
The Food and Drug Administration (FDA) approved Cinvanti™ (aprepitant injection) in combination with other antiemetic agents for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin and for nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Source: FDA website
New Drug 11-10-17
Heplisav
The Food and Drug Administration (FDA) approved Heplisav-B™ (hepatitis B vaccine injection) for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. Source: FDA website
New Drug 11-10-17
Abilify MyCIte
The Food and Drug Administration (FDA) approved Abilify MyCite® (aripiprazole tablets with sensor) for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder and for use as an add-on treatment for depression in adults. It has an ingestible sensor embedded in the tablet that records that the medication was taken. Source: FDA website
New Drug 11-14-17
Fasenra
The Food and Drug Administration (FDA) approved Fasenra™ (benralizumab injection) for the add-on maintenance treatment of severe eosinophilic asthma in patients at least 12 years old. Source: FDA website
New Drug 11-14-17
Mepsevii
The Food and Drug Administration (FDA) approved Mepsevii™ (vestronidase alfa injection) for the treatment of adults and children with mucopolysaccharidosis VII (MPS VII). Source: FDA website
New Drug 11-15-17
Hemlibra
The Food and Drug Administration (FDA) approved Hemlibra® (emicizumab-kxwh injection) to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A who have developed antibodies called Factor VIII inhibitors. Source: FDA website
New Drug 11-16-17
Uloric
The Food and Drug Administration (FDA) announced preliminary results from a safety clinical trial showing an increased risk of heart-related death with Uloric® (febuxostat) compared to another gout medication called allopurinol. Once final results are received, the FDA will conduct a review and update the public with new information. Contact your healthcare provider with any questions. More details are available at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm585281.htm Source: FDA website
Drug Warning 11-15-17
Repatha
The Food and Drug Administration (FDA) approved Repatha® (evolocumab injection) to prevent myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease. It was also approved as an adjunct to diet, alone or in combination with other lipid-lowering therapies such as statins, for the treatment of adults with primary hyperlipidemia to reduce low-density lipoprotein (LDL) cholesterol. Source: FDA website
New Indication 12-1-17
Taltz
The Food and Drug Administration (FDA) approved Taltz® (ixekizumab injection) for the treatment of adults with active psoriatic arthritis. Source: FDA website
New Indication 12-2-17
Impoyz
The Food and Drug Administration (FDA) approved Impoyz™ (clobetasol propionate 0.025% cream) for the treatment of moderate-to-severe plaque psoriasis in adults. Source: FDA website
New Drug 12-1-17
Lonhala Magnair
The Food and Drug Administration (FDA) approved Lonhala™ Magnair™ (glycopyrrolate oral inhalation solution) for the long-term, maintenance treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Source: FDA website
New Drug 12-5-17
Ozempic
The Food and Drug Administration (FDA) approved Ozempic® (semaglutide injection) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Source: FDA website
New Drug 12-5-17
Pharmacist Choice alcohol prep pads
Simple Diagnostics announced a voluntary recall of three lots of Pharmacist Choice alcohol prep pads due to lack of sterility assurance and other quality issues. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm587711.htm Source: FDA website
Drug Recall 12-5-17
Nucala
The Food and Drug Administration (FDA) approved Nucala® (mepolizumab injection) for the treatment of adults with eosinophilic granulomatosis with polyangiitis (EGPA). Source: FDA website
New Indication 12-12-17
Xeljanz; Xeljanz XR
The Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib tablets) and Xeljanz XR® (tofacitinib extended-release tablets) to treat adults with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs. Source: FDA website
New Indication 12-15-17
Cabometyx
The Food and Drug Administration (FDA) approved Cabometyx® (cabozantinib tablets) for previously untreated advanced renal cell carcinoma. Source: FDA website
New Indication 12-19-17
Bosulif
The Food and Drug Administration (FDA) approved Bosulif® (bosutinib tablets) for the treatment of adults with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia. Source: FDA website
New Indication 12-19-17
Xepi
The Food and Drug Administration (FDA) approved Xepi™ (ozenoxacin topical cream) for the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adults and children 2 months of age and older. Source: FDA website
New Drug 12-13-17
Eskata
The Food and Drug Administration (FDA) approved Eskata™ (hydrogen peroxide 40% topical solution) for the treatment of raised seborrheic keratoses. Source: FDA website
New Drug 12-15-17
Prexxartan
The Food and Drug Administration (FDA) approved Prexxartan® (valsartan oral solution) for the treatment of hypertension in adults and children 6 years and older, the treatment of heart failure, and to reduce the risk of cardiovascular death in clinically stable individuals with left ventricular failure or left ventricular dysfunction following myocardial infarction who are unable to swallow valsartan tablets. Source: FDA website
New Drug 12-19-17
Rhopressa
The Food and Drug Administration (FDA) approved Rhopressa® (netarsudil ophthalmic solution) to reduce intraocular pressure (IOP) in open-angle glaucoma (OAG) or ocular hypertension. Source: FDA website
New Drug 12-18-17
Luxturna
"The Food and Drug Administration (FDA) approved Luxturna® (voretigene neparvovec subretinal injection) for the treatment of individuals with confirmed biallelic RPE65 mutation-associated retinal dystrophy. Source: FDA website"
New Drug 12-19-17
Gadolinium-based contrast agents
The Food and Drug Administration (FDA) is requiring a class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) regarding gadolinium remaining in in the body for months to years after receiving these drugs. The FDA has concluded that the benefit of all approved GBCAs outweighs any potential risks; however is requiring these safety actions. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm589580.htm Source: FDA website
Drug Warning 12-19-17
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the adjuvant treatment of individuals with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Source: FDA website
New Indication 12-20-17
Perjeta
The Food and Drug Administration (FDA) approved Perjeta® (pertuzumab injection) in combination with Herceptin® (trastuzumab injection) and chemotherapy, for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence. Source: FDA website
New Indication 12-20-17
Procysbi
The Food and Drug Administration (FDA) approved Procysbi® (cysteamine bitartrate delayed-release capsules) to include children one year and older for the treatment of nephropathic cystinosis. Source: FDA website
New Indication 12-27-17
Xgeva (denosumab)
The Food and Drug Administration (FDA) approved Xgeva® (denosumab injection) for the prevention of skeletal-related events in individuals with multiple myeloma. Source: FDA website
New Indication 01-05-18
Siklos
The Food and Drug Administration (FDA) approved Siklos (hydroxyurea tablets) to reduce the frequency of painful crises and the need for blood transfusions in pediatric individuals 2 years of age and older with sickle cell anemia with recurrent moderate to severe painful crises. Source: FDA website
New Drug 12-21-17
Steglatro
The Food and Drug Administration (FDA) approved Steglatro™ (ertugliflozin tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2DM). Source: FDA website
New Drug 12-21-17
Steglujan
The Food and Drug Administration (FDA) approved Steglujan™ (ertugliflozin/sitagliptin tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate. Source: FDA website
New Drug 12-21-17
Segluromet
The Food and Drug Administration (FDA) approved Segluromet™ (ertugliflozin/metformin tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing ertugliflozin or metformin, or in patients who are already treated with both ertugliflozin and metformin. Source: FDA website
New Drug 12-21-17
Trulance
The Food and Drug Administration (FDA) approved Trulance® (plecanatide tablets) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). Source: FDA website
New Indication 01-25-18
Zomacton
The Food and Drug Administration (FDA) approved Zomacton™ (somatropin injection) for the replacement of growth hormone (GH) in adults with GH deficiency. Source: FDA website
New Indication 02-01-18
Avycaz
The Food and Drug Administration (FDA) approved Avycaz® (ceftazidime/avibactam injection) to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) in patients aged 18 years and older caused by susceptible Gram-negative microorganisms. Source: FDA website
New Indication 02-01-18
Firvanq
The Food and Drug Administration (FDA) approved Firvanq™ (vancomycin oral solution) for the treatment of Clostridium difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains. Source: FDA website
New Drug 01-29-18
Lutathera
The Food and Drug Administration (FDA) approved Lutathera® (lutetium Lu 177 dotatate injection), a radiopharmaceutical, for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) affecting the foregut, midgut, and hindgut. Source: FDA website
New Drug 01-26-18
Gericare Eye Wash
Kareway announced a voluntary recall of 60,000 lots of Gericare Eye Wash sterile eye irrigation solution due to the potential for product contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm595090.htm Source: FDA website
Drug Recall 02-02-18
Senna Laxative
Magno-Humphries Laboratories announced a recall of one lot of Basic Drugs brand of senna laxative tablets 8.6 mg due to mislabeling. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm593201.htm Source: FDA website
Drug Recall 01-23-18
Imodium
The Food and Drug Administration (FDA) is working with manufacturers to use blister packs or other single dose packaging and to limit the number of doses in a package for Imodium® (loperamide) over-the-counter (OTC) anti-diarrhea drug. The goal is to encourage safe use. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm594403.htm Source: FDA website
Drug Warning 01-30-18
Feraheme
The Food and Drug Administration (FDA) approved Feraheme® (ferumoxytol injection) expanded use to include all eligible adults with iron deficiency anemia who have intolerance to oral iron or have had unsatisfactory response to oral iron. Source: FDA website
New Indication 02-05-18
Zytiga
The Food and Drug Administration (FDA) approved Zytiga® (abiraterone acetate tablets) for use in combination with prednisone for the treatment of individuals with metastatic high-risk castration-sensitive prostate cancer (CSPC). Source: FDA website
New Indication 02-08-18
HyperRAB
The Food and Drug Administration (FDA) approved HyperRAB® (rabies immune globulin injection) for rabies post-exposure prophylaxis. This new formulation has a higher potency than existing product. Source: FDA website
New Drug 02-06-18
Biktarvy
The Food and Drug Administration (FDA) approved Biktarvy® (bictegravir/emtricitabine/tenofovir alafenamide tablets) for the treatment of human immunodeficiency virus (HIV)-1 infection in adults who are treatment naïve or experienced. Source: FDA website
New Drug 02-07-18
Symfi Lo
The Food and Drug Administration (FDA) approved Symfi Lo™ (efavirenz/lamivudine/tenofovir disoproxil fumarate tablets) for the treatment of human immunodeficiency virus (HIV)-1 infection in adults and pediatric individuals weighing 35 kg or greater. Source: FDA website
New Drug 02-05-18
Latuda
The Food and Drug Administration (FDA) approved Latuda® (lurasidone tablets) for the treatment of major depressive episode associated with bipolar I disorder (bipolar depression) in pediatric individuals aged 10 to 17 years. Source: FDA website
New Indication 03-07-18
Hizentra
The Food and Drug Administration (FDA) approved Hizentra® (immune globulin, human, 20% subcutaneous injection) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. Source: FDA website
New Indication 03-16-18
Trogarzo
The Food and Drug Administration (FDA) approved Trogarzo™ (ibalizumab-uiyk injection for intravenous use) for combination treatment of human immunodeficiency virus (HIV-1) infection in heavily treatment-experienced adults with multi-drug resistant (MDR) HIV-1 infection failing their current antiretroviral regimen. Source: FDA website
New Drug 03-06-18
Adcetris
The Food and Drug Administration (FDA) approved Adcetris® (brentuximab vedotin injection) in combination with chemotherapy in adults with previously untreated Stage III or IV classical Hodgkin lymphoma. Source: FDA website
New Indication 03-20-18
Tasigna
The Food and Drug Administration (FDA) approved Tasigna® (nilotinib capsules) for use in first and second line pediatric individuals 1 year and older with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase. Source: FDA website
New Indication 03-22-18
Toujeo Max SoloStar
The Food and Drug Administration (FDA) approved Toujeo® Max SoloStar® (insulin glargine 300 Units/mL) to improve glycemic control in adults with diabetes mellitus. Source: FDA website
New Formulation 03-27-18
Ilumya
The Food and Drug Administration (FDA) approved Ilumya™ (tildrakizumab-asmn injection) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Source: FDA website
New Drug 03-21-18
Alka-Seltzer Plus Products
Bayer announced a voluntary recall of selected Alka-Seltzer Plus® packages due to ingredients on front sticker possibly not matching product in carton. Please contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm601463.htm Source: FDA website
Drug Recall 03-16-18
Blincyto
The Food and Drug Administration (FDA) approved Blincyto® (blinatumomab injection) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD), Source: FDA website
New Indication 03-29-18
Leukine
The Food and Drug Administration (FDA) approved Leukine® (sargramostim injection) to increase survival in children and adults exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome (H-ARS). Source: FDA website
New Indication 03-30-18
Bydureon
The Food and Drug Administration (FDA) approved Bydureon® (exenatide extended-release injection) as an add-on to basal insulin in adults with type 2 diabetes who have inadequate glycemic control. Source: FDA website
New Indication 04-03-18
Rubraca
The Food and Drug Administration (FDA) approved Rubraca® (rucaparib tablets) as maintenance treatment for adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Source: FDA website
New Indication 04-06-18
Afinitor Disperz
The Food and Drug Administration (FDA) approved Afinitor Disperz® (everolimus tablets for oral suspension) for the adjunctive treatment of adult and pediatric individuals 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Source: FDA website
New Indication 04-10-18
Symfi (efavirenz/lamivudine/tenofovir disoproxil fumarate)
The Food and Drug Administration (FDA) approved Symfi™ (efavirenz/lamivudine/tenofovir disoproxil fumarate tablets) for the treatment of human immunodeficiency virus (HIV)-1 in adults and children weighing 40 kg or more. Symfi contains the same ingredients found in Symfi Lo but with a 600 mg dose of efavirenz versus 400 mg seen in Symfi Lo. Source: FDA website
New Formulation 03-28-18
Essure
The Food and Drug Administration (FDA) restricted sales of the Essure® permanent birth control system to only doctors and healthcare facilities who use the FDA-approved "Patient-Doctor Discussion Checklist - Acceptance of Risk and Informed Decision Acknowledgement". New labeling was also approved. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm604126.htm Source: FDA website
Drug Warning 04-09-18
Trelegy Ellipta
The Food and Drug Administration (FDA) approved Trelegy Ellipta for long-term, once-daily, maintenance treatment of airflow obstruction in individuals with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Source: FDA website
New Indication 04-24-18
Jynarque
The Food and Drug Administration (FDA) approved Jynarque™ (tolvaptan tablets) to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). Source: FDA website
New Drug 04-23-18
Lamictal
The Food and Drug Administration (FDA) warns that Lamictal® (lamotrigine) for seizures and bipolar disorder may cause a severe immune system reaction. A new warning will be added to the label. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm605628.htm Source: FDA website
Drug Warning 04-25-18
Mekinist and Tafinlar
The Food and Drug Administration (FDA) approved Mekinist® (trametinib tablets) and Tafinlar® (dabrafenib capsules) in combination for the adjuvant treatment of individuals with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection. Source: FDA website
New Indication 04-30-18
Mekinist and Tafinlar
The Food and Drug Administration (FDA) approved Mekinist® (trametinib tablets) and Tafinlar® (dabrafenib capsules) in combination for the treatment of anaplastic thyroid cancer (ATC) that is BRAF V600E mutation positive and either cannot be surgically excised or is metastatic. Source: FDA website
New Indication 05-04-18
Myrbetriq
The Food and Drug Administration (FDA) approved Myrbetriq® (mirabegron extended-release tablets) in combination with solifenacin succinate for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Source: FDA website
New Indication 04-30-18
Kymriah
The Food and Drug Administration (FDA) approved Kymriah™ (tisagenlecleucel injection) for the treatment of adults with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Source: FDA website
New Indication 05-01-18
Andexxa
The Food and Drug Administration (FDA) approved Andexxa® (coagulation factor Xa [recombinant] inactivated-zhzo) to reverse the anticoagulation effects of factor Xa inhibitors when needed due to life-threatening or uncontrolled bleeding. Source: FDA website
New Drug 05-04-18
Lyrica
The Food and Drug Administration (FDA) approved Lyrica® (pregabalin capsules and oral solution) as adjunctive therapy for the treatment of partial onset seizures in individuals as young as 4 years old. Source: FDA website
New Indication 05-07-18
Darzalex
The Food and Drug Administration (FDA) approved Darzalex® (daratumumab injection) in combination Velcade (bortezomib), melphalan, and prednisone for the treatment of individuals with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). Source: FDA website
New Indication 05-07-18
Gilenya
The Food and Drug Administration (FDA) approved Gilenya® (fingolimod capsules) for the treatment of children and adolescents with relapsing multiple sclerosis (MS) who are aged 10 years or older. Source: FDA website
New Indication 05-11-18
Plenvu
The Food and Drug Administration (FDA) approved Plenvu® (polyethylene glycol 3350/sodium ascorbate/sodium sulfate/ascorbic acid/sodium chloride/potassium chloride for oral solution) for cleansing of the colon in preparation for colonoscopy in adults. Source: FDA website
New Drug 05-07-18
Medline Remedy Essentials No-Rinse Cleansing Foam
The Food and Drug Administration (FDA) is advising healthcare providers and consumers to avoid using all lots of Medline Remedy Essentials No-Rinse Cleansing Foam due to a multistate outbreak of infection caused by Burkholderia cepacia. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm607371.htm Source: FDA website
Drug Warning 05-10-18
Briviact
The Food and Drug Administration (FDA) approved Briviact® (brivaracetam tablets and oral solution) as monotherapy and adjunctive therapy in the treatment of partial-onset seizures in individuals 4 years of age and older. Source: FDA website
New Indication 05-14-18
Actemra
The Food and Drug Administration (FDA) approved Actemra® (tocilizumab subcutaneous injection) for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in individuals aged 2 years and older, as monotherapy or in combination with methotrexate. Source: FDA website
New Indication 05-14-18
Truvada
The Food and Drug Administration (FDA) approved Truvada® (emtricitabine/tenofovir disoproxil fumarate tablets) in combination with safer sex practices to reduce the risk of sexually acquired human immunodeficiency virus (HIV)-1 infection in at-risk adolescents. Source: FDA website
New Indication 05-15-18
Lucemyra
The Food and Drug Administration (FDA) approved Lucemyra™ (lofexidine tablets) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. Source: FDA website
New Drug 05-16-18
Aimovig
The Food and Drug Administration (FDA) approved Aimovig™ (erenumab subcutaneous injection) for the prevention of migraines in adults. Source: FDA website
New Drug 05-17-18
Lokelma
The Food and Drug Administration (FDA) approved Lokelma™ (sodium zirconium cyclosilicate for oral suspension) for the treatment of adults with hyperkalemia. Source: FDA website
New Drug 05-18-18
Doptelet
The Food and Drug Administration (FDA) approved Doptelet® (avatrombopag tablets) for the treatment of thrombocytopenia in adults with chronic liver disease scheduled to undergo a procedure. Source: FDA website
New Drug 05-21-18
Dolutegravir
Serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir used to treat human immunodeficiency virus (HIV). Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608168.htm Source: FDA website
Drug Warning 05-18-18
MBI Distributing
MBI Distributing, Inc. announced a voluntary recall of all lots of unexpired homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir due to a lack of adequate controls during the manufacturing process. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608254.htm Source: FDA website
Drug Recall 05-21-18
Prolia
The Food and Drug Administration (FDA) approved Prolia® (denosumab injection) for the treatment of glucocorticoid-induced osteoporosis. Source: FDA website
New Indication 05-21-18
Arnuity Ellipta
The Food and Drug Administration (FDA) approved Arnuity® Ellipta® (fluticasone furoate oral inhalation) as once-daily asthma maintenance treatment for children as young as age 5 years. Source: FDA website
New Indication 05-22-18
Cimzia
The Food and Drug Administration (FDA) approved Cimzia® (certolizumab pegol injection) for adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Source: FDA website
New Indication 05-29-18
Xeljanz
The Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib tablets) for the treatment of adults with moderately to severely active ulcerative colitis. Source: FDA website
New Indication 05-30-18
Yonsa
The Food and Drug Administration (FDA) approved Yonsa® (abiraterone acetate tablets) micronized formulation for the treatment of metastatic castration-resistant prostate cancer in combination with methylprednisolone. Source: FDA website
New Drug 05-23-18
Imvexxy
The Food and Drug Administration (FDA) approved Imvexxy™ (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia, or vaginal pain during sexual activity caused by vulvar and vaginal atrophy during menopause. Source: FDA website
New Drug 05-30-18
Consensi
The Food and Drug Administration (FDA) approved Consensi™ (amlodipine/celecoxib tablets) for individuals for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Source: FDA website
New Drug 05-31-18
Palynziq
The Food and Drug Administration (FDA) approved Palynziq™ (pegvaliase-pqpz) to reduce blood phenylalanine concentrations in adults with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations >600 micromol/L on existing management. Source: FDA website
New Drug 05-29-18
Olumiant
The Food and Drug Administration (FDA) approved Olumiant® (baricitinib tablets) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to 1 or more tumor-necrosis factor (TNF) antagonists. Source: FDA website
New Drug 06-01-18
Benzocaine
The Food and Drug Administration (FDA) is warning that over-the-counter (OTC) oral products containing benzocaine should not be used to treat infants and children younger than 2 years. They are also warning that benzocaine oral drug products should only be used in adults and children 2 years and older if they contain certain warnings on the drug label due to the risk of serious and potentially fatal blood disorder. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608612.htm Source: FDA website
Drug Warning 05-23-18
Ethyl alcohol
Lake Michigan Distilling Company, doing business as Ethanol Extraction, announced a recall of its 95% Ethyl alcohol product due to possible contamination with methanol. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm608695.htm Source: FDA website
Drug Recall 05-24-18
Fluticasone propionate
Apotex announced a recall of fluticasone propionate nasal spray 50 mcg per spray due to the potential for small glass particles. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm609488.htm Source: FDA website
Drug Recall 05-31-18
Taytulla
Allergan announced a recall of Taytulla™ (norethindrone acetate/ethinyl estradiol capsules and ferrous fumarate capsules) due to out of sequence capsules. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm609064.htm Source: FDA website
Drug Recall 05-29-18
Alimta
The Food and Drug Administration (FDA) approved Alimta® (pemetrexed injection) in combination with carboplatin and Keytruda® (pembrolizumab injection) for the initial treatment of individuals with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression status. Source: FDA website
New Indication 06-05-18
Mircera
The Food and Drug Administration (FDA) approved Mircera® (methoxy polyethylene glycol-epoetin beta injection) for the treatment of pediatric individuals 5 to 17 years of age on hemodialysis who are converting from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA. Source: FDA website
New Indication 06-07-18
Rituxan
The Food and Drug Administration (FDA) approved Rituxan® (rituximab injection) for the treatment of moderate to severe pemphigus vulgaris. Source: FDA website
New Indication 06-08-18
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for individuals with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (combined positive score ≥1) as determined by an FDA-approved test. Source: FDA website
New Indication 06-12-18
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of adult and pediatric individuals with refractory primary mediastinal large B-cell lymphoma (PMBCL) or who have relapsed after two or more prior lines of therapy. Source: FDA website
New Indication 06-13-18
Venclexta
The Food and Drug Administration (FDA) approved Venclexta™ (venetoclax tablets) in combination with rituximab for the treatment of individuals with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy. Source: FDA website
New Indication 06-08-18
Avastin
The Food and Drug Administration (FDA) approved Avastin® (bevacizumab injection) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection. Source: FDA website
New Indication 06-13-18
Moxidectin
The Food and Drug Administration (FDA) approved Moxidectin tablets for the treatment of onchocerciasis (river blindness) due to Onchocerca volvulus in individuals ages 12 years and older. Source: FDA website
New Drug 06-14-18
Guardian Pharmacy Services
At least 43 individuals reported adverse events after receiving eye injections of Guardian's Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. Adverse events reported included vision impairment, poor night vision, loss of color perception, and significant reductions in best-corrected visual acuity and visual fields. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm610835.htm Source: FDA website
Drug Warning 06-14-18
Cinryze
The Food and Drug Administration (FDA) approved Cinryze® (C1 esterase inhibitor, human, injection) for the prevention of attacks in pediatric hereditary angioedema in individuals as young as 6 years. Source: FDA website
New Indication 06-21-18
Xeomin
The Food and Drug Administration (FDA) approved Xeomin® (incobotulinumtoxinA injection) for the treatment of excessive drooling in adults. Source: FDA website
New Indication 07-05-18
Nocdurna
The Food and Drug Administration (FDA) approved Nocdurna® (desmopressin acetate sublingual tablet) for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least two times per night to void. Source: FDA website
New Formulation 06-22-18
Qbrexza
The Food and Drug Administration (FDA) approved Qbrexza™ (glycopyrronium topical cloths) for the treatment of primary axillary hyperhidrosis in individuals ages 9 years and older. Source: FDA website
New Formulation 06-29-18
Aristada Initio
The Food and Drug Administration (FDA) approved Aristada Initio™ (aripiprazole lauroxil extended-release injectable suspension) in combination with oral aripiprazole for the initiation of Aristada in the treatment of adults with schizophrenia. Aristada Initio is not for repeated dosing. Source: FDA website
New Formulation 07-02-18
Epidiolex
The Food and Drug Administration (FDA) approved Epidiolex® (cannabidiol oral solution) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in individuals 2 years of age and older. Source: FDA website
New Drug 06-25-18
Zemdri
The Food and Drug Administration (FDA) approved Zemdri™ (plazomicin injection) for adults with complicated urinary tract infections including pyelonephritis, caused by certain Enterobacteriaceae in individuals who have limited or no alternative treatment options. Source: FDA website
New Drug 06-26-18
Braftovi and Mektovi
The Food and Drug Administration (FDA) approved Braftovi® (encorafenib) and Mektovi™ (binimetinib) in combination for individuals with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. Source: FDA website
New Drug 06-27-18
Opdivo and Yervoy
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) and Yervoy (ipilimumab injection)® for the treatment of adult and pediatric individuals 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. Source: FDA website
New Indication 07-11-18
Intelence
The Food and Drug Administration (FDA) approved Intelence® (etravirine tablets) for treatment-experienced pediatric individuals 2 to <6 years of age weighing 10 kg or more for the treatment of human immunodeficiency virus (HIV)-1 infection, in combination with other antiretrovirals. Source: FDA website
New Indication 07-18-18
Zomacton
The Food and Drug Administration (FDA) approved Zomacton® (somatropin for subcutaneous injection) for the treatment of pediatric individuals with idiopathic short stature (ISS), short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by 2–4 years, and short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency. Source: FDA website
New Indication 07-19-18
Xtandi
The Food and Drug Administration (FDA) approved Xtandi® (enzalutamide capsules) for the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC). Source: FDA website
New Indication 07-16-18
Kisqali
The Food and Drug Administration (FDA) approved Kisqali® (ribociclib tablets) in combination with an aromatase inhibitor (AI) for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. Source: FDA website
New Indication 07-18-18
Perseris
The Food and Drug Administration (FDA) approved Perseris™ (risperidone extended-release subcutaneous injection) for once-monthly treatment of schizophrenia in adults. Source: FDA website
New Formulation 07-27-18
Symtuza
The Food and Drug Administration (FDA) approved Symtuza™ (darunavir/cobicistat/emtricitabine/tenofovir alafenamide tablets) for the treatment of adults with human immunodeficiency virus (HIV)-1 infection who are treatment-naïve or virologically suppressed on a stable antiretroviral regimen for 6 or more months with no known darunavir or tenofovir resistance substitutions. Source: FDA website
New Drug 07-18-18
Orilissa
The Food and Drug Administration (FDA) approved Orilissa™ (elagolix tablets) for the management of moderate to severe endometriosis-associated pain. Source: FDA website
New Drug 07-24-18
Krintafel
The Food and Drug Administration (FDA) approved Krintafel™ (tafenoquine tablets) for the prevention of relapse of Plasmodium vivax malaria in individuals aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection. Source: FDA website
New Drug 07-23-18
TPOXX
The Food and Drug Administration (FDA) approved TPOXX® (tecovirimat capsules) for the treatment of human smallpox disease in adults and pediatric individuals weighing at least 13 kg. Source: FDA website
New Drug 07-16-18
Tibsovo
The Food and Drug Administration (FDA) approved Tibsovo® (ivosidenib tablets) for the treatment of relapsed or refractory acute myeloid leukemia (AML) in adults with a susceptible IDH1 mutation as detected by an FDA approved test. Source: FDA website
New Drug 07-20-18
Fluoroquinolone antibiotics
The Food and Drug Administration (FDA) is strengthening current warnings in the prescribing label that fluoroquinolone antibiotics may cause significant decreases in blood sugar and certain mental health side effects. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm612979.htm Source: FDA website
Drug Warning 07-10-18
Ranier's Compounding Laboratory
The Food and Drug Administration (FDA) is alerting health care providers and consumers not to use drug products intended to be sterile that are produced and distributed by Ranier's Compounding Laboratory due to lack of sterility assurance. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/drugs/drugsafety/ucm612911.htm Source: FDA website
Drug Recall 07-10-18
Valsartan containing product
The Food and Drug Administration (FDA) announced a recall on valsartan products containing an impurity, N-nitrosodimethylamine (NDMA), a potentially cancer-causing substance. Contact your healthcare provider with any questions. More details including affected products may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm614030.htm Source: FDA website
Drug Recall 07-19-18
Kalydeco
The Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor tablets and oral granules) to include use in children aged at least 12 months but younger than 24 months who carry at least one responsive CFTR mutation. Source: FDA website
New Indication 08-15-18
Lenvima
The Food and Drug Administration (FDA) approved Lenvima® (lenvatinib capsules) for first-line treatment of individuals with unresectable hepatocellular carcinoma. Source: FDA website
New Indication 08-16-18
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the treatment of individuals with small cell lung cancer (SCLC) with disease progression following two or more lines of therapy. Source: FDA website
New Indication 08-16-18
Cequa
The Food and Drug Administration (FDA) approved Cequa™ (cyclosporine ophthalmic solution) to increase tear production in individuals with keratoconjunctivitis sicca (dry eye). Source: FDA website
New Drug 08-16-18
Imbruvica
The Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib tablets and capsules) for combination use with rituximab for the treatment of adults with Waldenström's macroglobulinemia (WM). Source: FDA website
New Indication 08-27-18
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination with pemetrexed and platinum chemotherapy for the first-line treatment of individuals with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Source: FDA website
New Indication 08-20-18
Altreno
The Food and Drug Administration (FDA) approved Altreno™ (tretinoin lotion) for the treatment of acne vulgaris in individuals 9 years of age and older. Source: FDA website
New Formulation 08-24-18
Inveltys
The Food and Drug Administration (FDA) approved Inveltys™ (loteprednol etabonate ophthalmic suspension) for the treatment of post-operative inflammation and pain following ocular surgery. Source: FDA website
New Drug 08-23-18
Oxervate
The Food and Drug Administration (FDA) approved Oxervate™ (cenegermin ophthalmic solution) for the treatment of neurotrophic keratitis. Source: FDA website
New Drug 08-22-18
Takhzyro
The Food and Drug Administration (FDA) approved Takhzyro™ (lanadelumab-flyo injection) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in individuals 12 years and older. Source: FDA website
New Drug 08-23-18
Diacomit
The Food and Drug Administration (FDA) approved Diacomit® (stiripentol oral capsules and powder) for the treatment of seizures associated with Dravet syndrome in individuals 2 years of age and older taking clobazam. Source: FDA website
New Drug 08-23-18
Xerava
The Food and Drug Administration (FDA) approved Xerava™ (eravacycline injection) for the treatment of complicated intra-abdominal infections in individuals 18 years of age and older. Source: FDA website
New Drug 08-27-18
Torrent Pharmaceuticals
Torrent Pharmaceuticals Limited announced a voluntary recall of all lots of valsartan/amlodipine/HCTZ and valsartan tablets due to the detection of trace amounts of an unexpected impurity. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm617821.htm Source: FDA website
Drug Recall 08-21-18
King Bio
King Bio announced a voluntary recall of its Kids and Infant products due to potential microbial contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm617945.htm Source: FDA website
Drug Recall 08-22-18
Jivi
The Food and Drug Administration (FDA) approved Jivi® (antihemophilic factor, recombinant, PEGylated-aucl injection) approved for the treatment of hemophilia A. Source: FDA website
New Drug 08-30-18
Pifeltro
The Food and Drug Administration (FDA) approved Pifeltro™ (doravirine tablets) in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection in adults with no prior antiretroviral treatment history. Source: FDA website
New Drug 08-30-18
Delstrigo
The Food and Drug Administration (FDA) approved Delstrigo™ (doravirine/lamivudine/tenofovir disoproxil fumarate tablets) as a complete regimen for the treatment of human immunodeficiency virus (HIV)-1 infection in adults with no antiretroviral treatment history. Source: FDA website
New Drug 08-30-18
Sodium-glucose cotransporter-2 (SGLT2) inhibitors
The Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. A new warning about this risk will be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm618908.htm Source: FDA website
Drug Warning 08-29-18
Hydrochlorothiazide
Accord Healthcare announced a voluntary recall of one lot of hydrochlorothiazide tablets 12.5 mg due to a labeling mix-up. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm618583.htm Source: FDA website
Drug Recall 08-28-18
Children's Advil
Pfizer announced a voluntary recall of one lot of Children's Advil® due to dosage cup mislabeling. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm618675.htm Source: FDA website
Drug Recall 08-28-18
Quest Manufacturing
Quest Manufacturing announced they are expanding their voluntary recall of CVS Health 12 Hour Sinus Relief Nasal Mist to include all lots of nasal products and baby oral gels within expiration that were manufactured at the company’s Florida facility due to possible microbial contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm618803.htm Source: FDA website
Drug Recall 08-29-18
Weight Away Remedy
Living Well Remedies announced a voluntary recall of one lot of Weight Away Remedy due to microbial contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm618669.htm Source: FDA website
Drug Recall 08-28-18
HelloLife
HelloLife, Inc. announced a voluntary recall of all lots within expiration of Neuroveen™, Respitrol™, Thyroveev™ and Compulsin™ due to possible microbial contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm618926.htm Source: FDA website
Drug Recall 08-31-18
Tiglutik
The Food and Drug Administration (FDA) approved Tiglutik™ (riluzole oral suspension) for the treatment of amyotrophic lateral sclerosis (ALS). Source: FDA website
New Formulation 09-06-18
Cassipa
The Food and Drug Administration (FDA) approved Cassipa (buprenorphine/naloxone sublingual film) for the maintenance treatment of opioid dependence. Source: FDA website
New Formulation 09-07-18
Montelukast sodium
The Food and Drug Administration (FDA) is warning about a voluntary recall of one lot of montelukast sodium tablets by Camber Pharmaceuticals due to incorrect drug in bottles. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm619825.htm Source: FDA website
Drug Recall 08-31-18
Beaumont Bio Med
Beaumont Bio Med announced a voluntary recall of all unexpired aqueous/alcohol-based products due to possible microbial contamination. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm619587.htm Source: FDA website
Drug Recall 09-05-18
Xarelto
The Food and Drug Administration (FDA) approved Xarelto® (rivaroxaban tablets) to reduce the risk of major cardiovascular (CV) events, such as CV death, myocardial infarction (MI) and stroke, in people with chronic coronary or peripheral artery disease (CAD/PAD). Source: FDA website
New Indication 10-11-18
Liletta
The Food and Drug Administration (FDA) approved Liletta® (levonorgestrel-releasing intrauterine system) to prevent pregnancy for up to 5 years. Source: FDA website
New Indication 10-16-18
Stiolto Respimat
The Food and Drug Administration (FDA) approved Stiolto® Respimat® (tiotropium bromide/olodaterol oral inhalation) for long-term, once-daily maintenance treatment of individuals with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Source: FDA website
New Indication 10-11-18
Yutiq
The Food and Drug Administration (FDA) approved YutiqTM (fluocinolone acetonide intravitreal implant) for the treatment of chronic, non-infectious uveitis affecting the posterior segment of the eye. Source: FDA website
New Drug 10-15-18
Talzenna
The Food and Drug Administration (FDA) approved TalzennaTM (talazoparib capsules) for individuals with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2 negative locally advanced or metastatic breast cancer based on an FDA-approved companion diagnostic. Source: FDA website
New Drug 10-16-18
Sprayology
Sprayology announced a voluntary recall of all lots within expiry from 10/18-07/22 of its aqueous-based homeopathic product line for human use due to possible microbial contamination. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm622919.htm Source: FDA website
Drug Recall 10-11-18
Actemra SC
The Food and Drug Administration (FDA) approved Actemra® (tocilizumab subcutaneous injection) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) alone or in combination with methotrexate in individuals 2 years of age or older. Source: FDA website
New Indication 09-13-18
Xelpros
The Food and Drug Administration (FDA) approved Xelpros™ (latanoprost ophthalmic emulsion) for the reduction of elevated intraocular pressure (IOP) in individuals with open-angle glaucoma or ocular hypertension. Source: FDA website
New Formulation 09-14-18
Lumoxiti
The Food and Drug Administration (FDA) approved Lumoxiti™ (moxetumomab pasudotox injection) for adults with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies including treatment with a purine nucleoside analog (PNA). Source: FDA website
New Drug 09-13-18
Years to Your Health
The Food and Drug Administration (FDA) is alerting consumers not to use any products made by Years to Your Health of Irving, Texas due to risk for serious infection. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Drugs/DrugSafety/ucm620564.htm Source: FDA website
Drug Warning 09-14-18
Furosemide
SCA Pharmaceuticals announced a voluntary recall of 7 lots of the injectable product furosemide 100 mg in 0.9% sodium chloride 100 mg bag due to visible particulate matter. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm619776.htm Source: FDA website
Drug Recall 09-06-18
Pharm D Solutions
Pharm D Solutions announced a voluntary recall of all sterile compounded drugs due to a potential lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm620054.htm Source: FDA website
Drug Recall 09-11-18
Coagadex
The Food and Drug Administration (FDA) approved Coagadex® (coagulation factor X, human, injection) in adults and children for routine prophylaxis to prevent or reduce the frequency of bleeding episodes and for perioperative management of bleeding to include individuals with moderate hereditary Factor X deficiency. Source: FDA website
New Indication 09-26-18
Fycompa
The Food and Drug Administration (FDA) approved Fycompa® (perampanel tablets and oral suspension) in pediatric individuals as young as 4 years old for the treatment of partial-onset seizures. Source: FDA website
New Indication 09-28-18
Xolair
The Food and Drug Administration (FDA) approved Xolair® (omalizumab injection) prefilled syringe formulation for the treatment of allergic asthma and chronic idiopathic urticaria. Source: FDA website
New Formulation 10-01-18
Xyosted
The Food and Drug Administration (FDA) approved Xyosted™ (testosterone auto-injection) for once weekly testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone. Source: FDA website
New Formulation 10-01-18
Symjepi
The Food and Drug Administration (FDA) approved Symjepi™ (epinephrine injection) 0.15 mg dose to treat anaphylaxis in pediatric individuals who weigh between 33 and 65 pounds. Source: FDA website
New Formulation 09-28-18
Arikayce
The Food and Drug Administration (FDA) approved Arikayce® (amikacin liposome oral inhalation suspension) for the treatment of Mycobacterium avium complex (MAC) in individuals who do not respond to conventional treatment. Source: FDA website
New Drug 09-28-18
Ajovy
The Food and Drug Administration (FDA) approved Ajovy™ (fremanezumab injection) for the prevention of chronic and episodic migraine headaches in adults. Source: FDA website
New Drug 09-17-18
Copiktra
The Food and Drug Administration (FDA) approved Copiktra™ (duvelisib capsules) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after 2 or more prior therapies and relapsed or refractory follicular lymphoma (FL) after 2 or more prior therapies. Source: FDA website
New Drug 09-14-18
Vizimpro
The Food and Drug Administration (FDA) approved Vizimpro® (dacomitinib tablets) for first-line treatment of individuals with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. Source: FDA website
New Drug 09-27-18
Emgality
The Food and Drug Administration (FDA) approved Emgality™ (galcanezumab injection) for the prevention of chronic and episodic migraine headaches in adults. Source: FDA website
New Drug 09-27-18
Libtayo
The Food and Drug Administration (FDA) approved Libtayo® (cemiplimab injection) for the treatment of individuals with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Source: FDA website
New Drug 09-28-18
Zhejiang Huahai Pharmaceuticals
The Food and Drug Administration (FDA) placed Zhejiang Huahai Pharmaceuticals on import alert while the active pharmaceutical ingredient (API) manufacturer determines how impurities were introduced into its valsartan products. Contact your healthcare provider with questions. Details may be viewed at: https://www.fda.gov/drugs/drugsafety/ucm613916.htm Source: FDA website
Drug Warning 09-28-18
Pen Needles
The Food and Drug Administration (FDA) is providing recommendations to promote the safe use of pen needles used to inject medications from pen injectors. Contact your healthcare provider with questions. Details may be viewed at: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm621788.htm Source: FDA website
Drug Warning 09-27-18
Biolyte Laboratories
BioLyte Laboratories announced a voluntary recall of certain lots of NeoRelief, a homeopathic topical gel for muscle cramping and restlessness, due to possible microbial contamination. Contact your healthcare provider with questions. Details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm620481.htm Source: FDA website
Drug Recall 09-12-18
Robaxin
Endo International announced a voluntary recall of 2 lots of Robaxin 750 mg tablets 100 count bottle packs due to incorrect daily dosing information on label. Contact your healthcare provider with questions. Details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm622008.htm Source: FDA website
Drug Recall 09-28-18
Humira
The Food and Drug Administration (FDA) approved Humira® (adalimumab injection) for the treatment of hidradenitis suppurativa in adolescents. Source: FDA website
New Indication 10-16-18
Dupixent
The Food and Drug Administration (FDA) approved Dupixent® (dupilumab injection) as an add-on maintenance therapy in individuals with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Source: FDA website
New Indication 10-19-18
Afluria, Afluria Quadrivalent
The Food and Drug Administration (FDA) approved Afluria® (trivalent, inactivated influenza vaccine injection) and Afluria® Quadrivalent (quadrivalent, inactivated influenza vaccine injection) for use in individuals 6 months and older. Both were previously indicated for individuals 5 years of age and older. Source: FDA website
New Indication 10-23-18
Xyrem
The Food and Drug Administration (FDA) approved Xyrem® (sodium oxybate oral solution) for the treatment of cataplexy and excessive daytime sleepiness (EDS) in pediatric individuals ages 7 to 17 years old with narcolepsy. Source: FDA website
New Indication 10-26-18
Invokana
The Food and Drug Administration (FDA) approved Invokana® (canagliflozin tablets) to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes who have established CV disease. Source: FDA website
New Indication 10-30-18
Invokamet, Invokamet XR
The Food and Drug Administration (FDA) approved Invokamet® (canagliflozin/metformin tablets) and Invokamet® XR (canagliflozin/metformin extended-release tablets) to reduce the risk of major adverse cardiovascular (CV) events in adults with type 2 diabetes who have established CV disease. Source: FDA website
New Indication 10-30-18
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) in combination with carboplatin and either paclitaxel or nab-paclitaxel for first-line treatment of squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression. Source: FDA website
New Indication 10-30-18
Sympazan
The Food and Drug Administration (FDA) approved Sympazan™ (clobazam oral film) as adjunct treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in individuals aged 2 years and older. Source: FDA website
New Formulation 11-05-18
Qmiiz ODT
The Food and Drug Administration (FDA) approved Qmiiz ODT™ (meloxicam orally disintegrating tablets) for the treatment of osteoarthritis, rheumatoid arthritis, and juvenile idiopathic arthritis. Source: FDA website
New Formulation 10-19-18
Egrifta
The Food and Drug Administration (FDA) approved Egrifta™ (tesamorelin injection) single-vial formulation for the treatment of excess abdominal visceral adipose tissue (VAT) in human immunodeficiency virus (HIV)-infected individuals with lipodystrophy. Source: FDA website
New Formulation 11-05-18
Khapzory
The Food and Drug Administration (FDA) approved Khapzory™ (levoleucovorin injection) for rescue after high-dose methotrexate therapy in individuals with osteosarcoma, diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination, and the treatment of individuals with metastatic colorectal cancer in combination with fluorouracil. Source: FDA website
New Formulation 10-23-18
Bijuva
The Food and Drug Administration (FDA) approved Bijuva (estradiol/progesterone capsules) for the treatment of moderate to severe vasomotor symptoms due to menopause in women who have a uterus. Source: FDA website
New Formulation 10-29-18
Dsuvia
The Food and Drug Administration (FDA) approved Dsuvia (sufentanil sublingual tablets) for the management of acute pain in adults that is severe enough to require an opioid analgesic in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments. It is not intended for use beyond 72 hours. Source: FDA website
New Formulation 11-02-18
Lorbrena
The Food and Drug Administration (FDA) approved Lorbrena® (lorlatinib tablets) for individuals with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. Source: FDA website
New Drug 11-02-18
Xofluza
The Food and Drug Administration (FDA) approved Xofluza™ (baloxavir marboxil tablets) for the treatment of acute uncomplicated influenza in individuals 12 years of age and older who have been symptomatic for no more than 48 hours. Source: FDA website
New Drug 10-24-18
EpiPen
The Food and Drug Administration (FDA) is alerting consumers and healthcare providers that the labels attached to some EpiPen® (epinephrine 0.3mg auto-injectors) and EpiPen Jr® (epinephrine 0.15mg auto-injectors), and the authorized generic versions, may block access to the auto-injector and prevent the ability to easily access the product. Contact your healthcare provider with any questions. More details may be viewed at: https://www.drugs.com/fda_alerts.html Source: FDA website
Drug Warning 11-02-18
Genetic Tests
The Food and Drug Administration (FDA) warns against the use of many genetic tests with unapproved claims to predict patient response to specific medications. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm624725.htm Source: FDA website
Drug Warning 11-01-18
Aurobindo Pharma Limited
Aurobindo Pharma Limited announced a voluntary recall of 22 batches of irbesartan due to the presence of an impurity. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm624547.htm Source: FDA website
Drug Recall 10-26-18
Sciegen Pharmaceuticals
Sciegen Pharmaceuticals announced a voluntary recall of certain lots of irbesartan tablets due to detection of an impurity. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm624593.htm Source: FDA website
Drug Recall 10-30-18
Ortho-Novum 1/35 and Ortho-Novum 7/7/7
Janssen Pharmaceuticals announced a voluntary recall of one lot of Ortho-Novum® 1/35 (norethindrone/ethinyl estradiol tablets) and two lots of Ortho-Novum® 7/7/7 (norethindrone/ethinyl estradiol tablets) due to incorrect Veridate dispenser instructions. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm625012.htm Source: FDA website
Drug Recall 11-02-18
Promise Pharmacy
Promise Pharmacy announced a voluntary recall of one lot of prednisolone and gatifloxacin ophthalmic solution due to small particulate floating in the solution. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm623994.htm Source: FDA website
Drug Recall 10-22-18
Empliciti
The Food and Drug Administration (FDA) approved Empliciti® (elotuzumab injection) in combination with pomalidomide and dexamethasone for the treatment of adults with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor. Source: FDA website
New Indication 11-06-18
Bryhali
The Food and Drug Administration (FDA) approved Bryhali™ (halobetasol propionate topical lotion) for the treatment of plaque psoriasis in adults. Source: FDA website
New Formulation 11-07-18
Kadesh Incorporation
Kadesh, Inc. announced a voluntary recall of all lots of Puriton Eye Relief Drops due to non-sterile production conditions. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm625305.htm Source: FDA website
Drug Recall 11-07-18
Sandoz
Sandoz announced a voluntary recall of one lot of losartan potassium hydrochlorothiazide tablets 100mg/25mg due to the trace amount of an impurity. Contact your healthcare provider with any questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm625492.htm Source: FDA website
Drug Recall 11-09-18
Astagraf XL
The Food and Drug Administration (FDA) approved Astagraf XL® (tacrolimus extended-release capsules) for prophylaxis of organ rejection in kidney transplant in combination with other immunosuppressants in pediatric individuals 4 years of age and older. Source: FDA website
New Indication 11-29-18
Tecentriq
The Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab injection) in combination with bevacizumab, paclitaxel, and carboplatin, for the first-line treatment, of individuals with metastatic non-squamous non-small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Source: FDA website
New Indication 12-06-18
Dextenza
The Food and Drug Administration (FDA) approved Dextenza® (dexamethasone ophthalmic insert) for the treatment of ocular pain after ophthalmic surgery. Source: FDA website
New Formulation 12-03-18
Valsartan-containing products from Mylan
Mylan announced an expansion of its voluntary recall to include all lots of valsartan-containing products within expiry due to detection of trace amounts of impurity in the active pharmaceutical ingredient. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm627647.htm Source: FDA website
Drug Recall 12-05-18
Tris Pharma
Tris Pharma announced a voluntary recall of 3 lots of Infants' Ibuprofen Concentrated Oral Suspension due to higher concentrations of ibuprofen. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Safety/Recalls/ucm627780.htm Source: FDA website
Drug Recall 12-06-18
Viread
The Food and Drug Administration (FDA) approved Viread® (tenofovir disoproxil fumarate tablets) for use in chronic hepatitis B in individuals aged 2 to less 12 years old. Source: FDA website
New Indication 12-13-18
Nplate
The Food and Drug Administration (FDA) approved Nplate® (romiplostim injection) for pediatric individuals 1 year of age and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Source: FDA website
New Indication 12-14-18
Tolsura
The Food and Drug Administration (FDA) approved Tolsura™ (SUBA-itraconazole capsules) for the treatment of blastomycosis (pulmonary and extrapulmonary), histoplasmosis (including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis), and aspergillosis (pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy). The new formulation is expected to have improved bioavailability. Source: FDA website
New Formulation 12-12-18
Promise Pharmacy
The Food and Drug Administration (FDA) alerted health care providers and consumers not to use drug products intended to be sterile from Promise Pharmacy due to lack of sterility assurance. Contact your healthcare provider with questions. More details may be viewed at: https://www.fda.gov/Drugs/DrugSafety/ucm627929.htm Source: FDA website
Drug Recall 12-07-18